At NuVasive, we transform surgery, advanced care, and change lives. You should always talk to your healthcare professional for diagnosis and treatment. List of devices made by the manufacturer NUVASIVE, INC. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 You should always talk to your healthcare professional for diagnosis and treatment. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Login - NuVasive Company Store - Direct EDJE The site is secure. It will also discuss the Simplify Medical transaction at that time. 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. At NuVasive, we aspire to change a patients life every minute. Transpsoas access 4. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Neurostimulators & Components. At NuVasive, we transform surgery, advanced care, and change lives. 50 - 99 pieces - 8,75. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. Globus Medical eyes acquisition of spinal implant maker NuVasive Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) Journal of Neurosurgery Spine. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. 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 Website www.nuvasive.com. %%EOF 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. 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. NUVASIVE: 2012022 SKU# 2012022-WE1. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 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). JavaScript seems to be disabled in your browser. 1 Terran J, Schwab F, Shaffrey CI, et al. All rights reserved. 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. NuVasive offers solutions to alleviate patient symptoms. All products sold by WestCMR are in-date. 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. NuVasive is the fastest growing, full-line spine company. Spine 2020;45(14):944-51. WestCMR does not provide advice, training, or clinical support. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. 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. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. $5,499.99. Transaction Details NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. PCF - NuVasive - PDF Catalogs | Technical Documentation The NuVasive TLIF philosophy, coupled with its comprehensive portfolio, provides open and MAS procedural systems that include the requisite tools surgeons need to plan surgery, access affected levels, restore alignment and disc height, provide optimized fixation, and deliver graft material. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Forward-Looking Statements var site_url = "https://www.medicaldevices24.com/"; About NuVasive 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. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto NuVasive funded the upfront payment at closing using available cash on hand. NuVasive provides patient support and surgeon education. The materials on this website are for your general educational information only. 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 its C360 portfolio. Elizabeth Hofheinz, M.P.H., M.Ed. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Unhappy? Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. You have not been assigned a username and password. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. About Simplify Medical gtag('js', new Date()); Based on review of publicly available materials at the time of this release. As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. window.dataLayer = window.dataLayer || []; On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. Lehr MA, Oner CF, Delawi D, et al. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Do not implant in patients under 18 years of age. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. 8050015: NuVasive NVM5 EMG Needle Module. Globus, which is a provider of implantable devices and instruments used in spinal and orthopedic surgeries, made an indicative cash-and-stock offer for NuVasive in recent weeks, the sources said. 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. NuVasive Launches Next-Gen Reline Spine Fixation System /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Prices excluding VAT and shipping.
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