nuvasive product catalog pdf

Learn how intelligent surgery can change your practice. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. Disc space preparation 5. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. %%EOF Sign in to add this product to your favorites! 3. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). PDF User Manual - Nuwave Cpap JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. 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. Elizabeth Hofheinz, M.P.H., M.Ed. Osteocel is human tissue donated specifically for human clinical use. 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. Prices excluding VAT and shipping. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. $1,299.99. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). At NuVasive, we transform surgery, advanced care, and change lives. 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. 2Data on file. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Make sure cookies are enabled in your browser. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. We do not practice medicine or provide medical services or advice as a part of this website. 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. Expected delivery: 3 weeks. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? 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. NuVasive funded the upfront payment at closing using available cash on hand. 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. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. SAN DIEGO February 24, 2021 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). An integrated technology platform to enable better spine surgery. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. NuVasive Inc Company Profile - GlobalData obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. NuVasive Launches Modulus ALIF. You should always talk to your healthcare professional for diagnosis and treatment. Robert Eastlack and Gregory Mundis. 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. (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 . Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. PDF Document Title: Visual and Cosmetic Standards for Manufacturing For more information, please visit www.nuvasive.com. gtag('js', new Date()); 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. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. 2.0 Scope *Data on file. This is why we show up every day, united and committed to our vision. 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. NuVasive provides patient support and surgeon education. All products | NuVasive Webshop multi-level pathologies. NuVasive is developing the operating room of the future. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. 50 - 99 pieces - 8,75. Excluding VAT and shipping. NuVasive offers solutions to alleviate patient symptoms. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. NuVasive is the fastest growing, full-line spine company. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. Open the catalog to page 2 What is causing my pain? Based on review of publicly available materials at the time of this release. NuVasive is the fastest growing, full-line spine company. NuVasive is developing the operating room of the future. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. All products sold by WestCMR are in-date. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. Peer-to-peer discussion between Drs. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Retroperitoneal access 3. 1997-2023 WestCMR. NuVasive provides patient support and surgeon education. Before sharing sensitive information, make sure you're on a federal government site. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! All rights reserved. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Excluding VAT and shipping. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. List of devices made by the manufacturer NUVASIVE, INC. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. 5. UPDATE: Potential Concerns with NuVasive Precice Devices Excluding VAT and shipping. 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 . If so, do not buy this item unless you are an authorized purchaser. By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. 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. COMPANY CONFIDENTIAL. NuVasive introduces new Reline 3D posterior fixation system 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. function gtag(){dataLayer.push(arguments);} The .gov means its official.Federal government websites often end in .gov or .mil. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. We do not practice medicine or provide medical services or advice as a part of this website. 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. Website www.nuvasive.com. 1. Expected delivery: 3 weeks. 1 Terran J, Schwab F, Shaffrey CI, et al. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. You have not been assigned a username and password. About Simplify Medical NUVASIVE: 2012022 SKU# 2012022-WE1. Address 7475 Lusk Blvd, San Diego, California, 92121. Excluding VAT and shipping. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. 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. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. The materials on this website are for your general educational information only. Becoming the number one partner in pediatrics. The Instructions for Use for titanium-based Precice devices have been updated to include: For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte): Note: Stainless steel-based Precice devices remain recalled from the U.S. market. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. 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. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. 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 The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. NuVasive offers solutions to alleviate patient symptoms. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. 1Simplify Cervical Artificial Disc P200022. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. Globus Medical eyes acquisition of spinal implant maker NuVasive Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. 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.. Product images are for display only. It will also discuss the Simplify Medical transaction at that time. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED Forward-Looking Statements Innovation in Musculoskeletal Solutions | Globus Medical 2. 2020 - Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System 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. Investor Conference Call Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. Returns are simple. Neurostimulators & Components. You should always talk to your healthcare professional for diagnosis and treatment. nuvasive product catalog pdf NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for COCCYX ZONE OF SPINE FOR. %PDF-1.5 % As of date of publication, March 2017; data on file. 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. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices.

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