nuvasive product catalog pdf

Excluding VAT and shipping. ALIF - NuVasive Retroperitoneal access 3. PDF User Manual - Nuwave Cpap We do not practice medicine or provide medical services or advice as a part of this website. Surgical efficiency meets reliable versatility. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. ET / 1:30 p.m. PT to discuss these results. Journal of Neurosurgery Spine. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. The materials on this website are for your general educational information only. (This story corrected name of Globus Medical in the headline from Global Medical). NuVasive Inc Company Profile - GlobalData These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. JavaScript seems to be disabled in your browser. NuVasive logo printed in 1 colour Prices (minimum order quantity 10 pieces) 10 - 24 pieces - 22,65 25 - 49 pieces - 19,30 50 - 100 pieces - 17,60 more than 100 pieces - please contact us for a new quote. The SRS-Schwab adult spinal deformity classification: NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. PLoS ONE 2011;6(10):1-8. PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). $1,299.99. 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. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. 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. 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. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 50 - 99 pieces - 8,75. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration NUVASIVE: 2012022 - WestCMR ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl About Simplify Medical An official website of the United States government, : Learn how intelligent surgery can change your practice. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, July 2021 letter to health care providers, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements, Division of Industry and Consumer Education (DICE), Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, Precice Intra-medullary Limb Lengthening Device. The materials on this website are for your general educational information only. 2. 1 Terran J, Schwab F, Shaffrey CI, et al. 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. 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 (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). NuVasive introduces new Reline 3D posterior fixation system hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. function gtag(){dataLayer.push(arguments);} 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. Globus Medical eyes acquisition of spinal implant maker NuVasive Becoming the number one partner in pediatrics. WestCMR does not provide advice, training, or clinical support. All products | NuVasive Webshop RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! PDF NVM5 Computer-Assisted Rod Bending Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto See here for a complete list of exchanges and delays. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. 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 NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Website www.nuvasive.com. COCCYX ZONE OF SPINE FOR. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- Alignment Matters . The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. This power bank is suitable for charging any device. $5,499.99. 1Simplify Cervical Artificial Disc P200022. One position. 888 0 obj <>stream Advisors The website is intended to provide information that might be of interest to users. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. 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. One comprehensive system. Simplify Medical is located in Sunnyvale, California. Returns are simple. 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. 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 is developing the operating room of the future. 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. Spine 2020;45(14):944-51. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. NuVasive is the fastest growing, full-line spine company. Do not implant more than two devices in a patient at once. 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. Based on review of publicly available materials at the time of this release. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Learn more about the value of Biologics Information you need When fusion is recommended The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. As of date of publication, March 2017; data on file. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. This is why we show up every day, united and committed to our vision. This service located at Oisto.com is a website owned and operated by Oisto. Expected delivery: 2 weeks. 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. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Appropriate patient positioning 2. Three New Biologic Products for Spine Surgery Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. multi-level pathologies. Unhappy? or more while undergoing treatment, and. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. 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). Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 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. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. 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. 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. Surgical efficiency. 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. 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 PDF eXtreme - SMISS Photos are for illustration purposes only and may not depict the exact item. About NuVasive In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. NuVasive provides patient support and surgeon education. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. 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. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. PCF - NuVasive - PDF Catalogs | Technical Documentation NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. 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. Robert Eastlack and Gregory Mundis. 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. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. Elizabeth Hofheinz, M.P.H., M.Ed. Peer-to-peer discussion between Drs. Neurostimulators & Components. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Reimagine cervical spine surgery. We do not practice medicine or provide medical services or advice as a part of this website. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. You should always talk to your healthcare professional for diagnosis and treatment. NuVasive provides patient support and surgeon education. 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.. To learn more, visit www.simplifymedical.com. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. It will also discuss the Simplify Medical transaction at that time. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| 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. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. 5. PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible Prices excluding VAT and shipping. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. All Trademarks referred to are the property of their respective owners. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. var site_url = "https://www.medicaldevices24.com/"; Sign in to add this product to your favorites! An integrated technology platform to enable better spine surgery. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. Expected delivery: 3 weeks. 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. var base_url = "https://www.medicaldevices24.com/"; Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. 789 0 obj <> endobj As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. 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). PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. Please close the page and access the Company Store via Okta.