nuvasive product catalog pdf
That no more than two devices should be implanted at a time. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. 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. Excluding VAT and shipping. Disc space preparation 5. Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. 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 provides patient support and surgeon education. We do not practice medicine or provide medical services or advice as a part of this website. D. Device Description Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE 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. Read the press release 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 . PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory 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. Elizabeth Hofheinz, M.P.H., M.Ed. Based on review of publicly available materials at the time of this release. Malone, H., Mundis, G. M., Jr., Collier, M, et al. NuVasive Company Profile - Office Locations, Competitors, Revenue All Trademarks & Logos belong to their respective owners. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Intelligently designed for fusion. Alignment. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. At NuVasive, we aspire to change a patients life every minute. 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. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. 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. Returns are simple. ALIF - NuVasive Polini A, Pisignano D, Parodi M, et al. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. The materials on this website are for your general educational information only. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. NuVasive offers solutions to alleviate patient symptoms. D. Device Description. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. 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. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. 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. 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 this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. Reline 3D, which is an extension to the NuVasive's Reline system, is part of the firm's comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. NuVasive provides patient support and surgeon education. 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. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. The site is secure. As of date of publication, March 2017; data on file. Duan R, Barbieri D, Luo X, et al. The subject Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. $1,299.99. 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. $5,499.99. Height 25cm, diameter 7cm - Volume: 500 ml. 789 0 obj <> endobj NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Sign in to add this product to your favorites! 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 industry leader for online information for tax, accounting and finance professionals. 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. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Advisors Investor Conference Call Headquarters United States of America. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected. iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. gtag('js', new Date()); $749.00. if( $robots ) : ?> An official website of the United States government, : One position. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Peer-to-peer discussion between Drs. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. All rights reserved. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. COCCYX ZONE OF SPINE FOR. All Trademarks referred to are the property of their respective owners. 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. 3. NuVasive Acquires Simplify Medical - NuVasive Open the catalog to page 2 What is causing my pain? The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. CODE: NS10000565. or more while undergoing treatment, and. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! You should always talk to your healthcare professional for diagnosis and treatment. NuVasive Inc Company Profile - GlobalData NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Implant insertion These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. $650.00. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. The SRS-Schwab adult spinal deformity classification: 1. 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. 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. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. Expected delivery: 3 weeks. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. 0 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. NuVasive offers solutions to alleviate patient symptoms. Excluding VAT and shipping. %%EOF The .gov means its official.Federal government websites often end in .gov or .mil. Appropriate patient positioning 2. All products sold by WestCMR are in-date. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. Journal of Neurosurgery Spine. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. For more information, please visit www.nuvasive.com. This is why we show up every day, united and committed to our vision. Expected delivery: 3 weeks. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Our Standards: The Thomson Reuters Trust Principles.
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