nuvasive product catalog pdf

Robert Eastlack and Gregory Mundis. Prices excluding VAT and shipping. An integrated technology platform to enable better spine surgery. Rethink how you buy and sell surgical supplies. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . We do not practice medicine or provide medical services or advice as a part of this website. Get your money back!. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P All Trademarks referred to are the property of their respective owners. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . %%EOF The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. NuVasive is the fastest growing, full-line spine company. Sign in to add this product to your favorites! This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. All products sold by WestCMR are in-date. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. 3. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. This power bank is suitable for charging any device. Height 25cm, diameter 7cm - Volume: 500 ml. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. endstream endobj startxref The materials on this website are for your general educational information only. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. var site_url = "https://www.medicaldevices24.com/"; NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Surgical efficiency. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. The Simplify Disc is supported by level-1 evidence through the FDA investigational device exemption (IDE) study1 and was found to be clinically superior to ACDF in the randomized controlled trial. Headquarters United States of America. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. Malone, H., Mundis, G. M., Jr., Collier, M, et al. $650.00. Do not implant more than two devices in a patient at once. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. Excluding VAT and shipping. December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. COCCYX ZONE OF SPINE FOR. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. Returns are simple. Advisors hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. You have not been assigned a username and password. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Please close the page and access the Company Store via Okta. 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream JavaScript seems to be disabled in your browser. Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. At NuVasive, we transform surgery, advanced care, and change lives. All rights reserved. At NuVasive, we transform surgery, advanced care, and change lives. This service located at Oisto.com is a website owned and operated by Oisto. The subject NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. 'VUJ)(h. 0 Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Journal of Neurosurgery Spine. function gtag(){dataLayer.push(arguments);} Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. Becoming the number one partner in pediatrics. Retroperitoneal access 3. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. Excluding VAT and shipping. 1 Terran J, Schwab F, Shaffrey CI, et al. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. The site is secure. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. Quantity: Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. $5,499.99. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). 888 0 obj <>stream NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Transpsoas access 4. NuVasive is developing the operating room of the future. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. You should always talk to your healthcare professional for diagnosis and treatment. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. As of date of publication, March 2017; data on file. Neurocare Products. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. from FortisBC Holdings Inc for C$400 million ($294.68 million). Biomater Sci 2018;6:136-45. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. Photos are for illustration purposes only and may not depict the exact item. See here for a complete list of exchanges and delays. NuVasive is developing the operating room of the future. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. The store will not work correctly in the case when cookies are disabled. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. For the best experience on our site, be sure to turn on Javascript in your browser. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Alignment. Disc space preparation 5. The materials on this website are for your general educational information only. *Data on file. Expected delivery: 3 weeks. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. All Trademarks & Logos belong to their respective owners. Do not implant in patients under 18 years of age. NuVasive is developing the operating room of the future. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. Simplify Medical is located in Sunnyvale, California. Product images are for display only. About Simplify Medical Price: $5.00 per kit. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. 5. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. 2Data on file. 2020 - 50 - 99 pieces - 8,75. One comprehensive system. Expected delivery: 3 weeks. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . The .gov means its official.Federal government websites often end in .gov or .mil. All rights reserved. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; At NuVasive, we aspire to change a patients life every minute. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. NUVASIVE: 2012022 SKU# 2012022-WE1. NuVasive is headquartered in San Diego, California, the US. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f You should always talk to your healthcare professional for diagnosis and treatment. List of devices made by the manufacturer NUVASIVE, INC. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. %PDF-1.4 % Unhappy? NuVasive funded the upfront payment at closing using available cash on hand. NuVasive provides patient support and surgeon education.

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