Data / Medical devices / Spinal Vertebral Body Replacement Device
Spinal Vertebral Body Replacement Device (MQP): 198 FDA-registered makers in 16 countries
198 establishments in 16 countries are registered with the FDA to make Spinal Vertebral Body Replacement Device (product code MQP, Class 2, 21 CFR 888.3060). 58 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 279 510(k) clearances under this code, the latest on July 31, 2026, and lists 19 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- MQP
- Device class
- 2
- Regulation
- 888.3060
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 144 |
| Germany | 13 |
| France | 13 |
| Switzerland | 11 |
| Taiwan | 3 |
| Malaysia | 3 |
| China | 2 |
| Costa Rica | 1 |
| Israel | 1 |
| Australia | 1 |
| Ireland | 1 |
| Belgium | 1 |
| South Korea | 1 |
| Netherlands | 1 |
| Canada | 1 |
| India | 1 |
Makers of Spinal Vertebral Body Replacement Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 32 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 20 | January 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Deggendorf GMBH | DEGGENDORF Bavaria, Germany | Manufacturer | 17 | March 14, 2007 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Manufacturer, Specification developer | 16 | May 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 14 | February 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 13 | May 1, 2008 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 13 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 13 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 11 | May 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 11 | February 26, 2020 | 0 | 1 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 11 | May 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 11 | May 23, 2019 | 0 | 1 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Complaint file establishment, Manufacturer, Specification developer | 8 | November 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| LDR Medical | Sainte-Savine Aube, France | Specification developer | 8 | May 16, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 8 | June 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 7 | June 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | February 24, 2006 | 0 | 1 | 0 | api.fda.gov |
| Spine Wave, Inc. | Shelton, CT, United States | Manufacturer, Specification developer | 6 | February 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 5 | October 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | October 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Signus Medizintechnik GMBH | ALZENAU Bavaria, Germany | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 5 | July 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 4 | October 6, 2023 | 0 | 1 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 4 | October 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | August 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ulrich GMBH & Co. KG | ULM Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 4 | November 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Choice Spine LLC | Knoxville, TN, United States | Complaint file establishment, Specification developer | 3 | February 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 3 | December 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 3 | December 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Camber Spine Technologies | King of Prussia, PA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | February 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| Icotec AG | Altstaetten Sankt Gallen, Switzerland | Complaint file establishment, Manufacturer | 2 | April 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| INNO Holdings Inc. | Millcreek, UT, United States | Manufacturer | 2 | December 22, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Medical Costa Rica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 2 | April 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 2 | February 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 2 | October 26, 2017 | 0 | 0 | 0 | api.fda.gov |
| RSB Spine LLC. | Wooster, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | June 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Trabecular Metal Technology, Inc. | Parsippany, NJ, United States | Contract manufacturer, Manufacturer | 2 | May 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Atlas Spine Inc. | Jupiter, FL, United States | Manufacturer | 1 | February 26, 2007 | 0 | 1 | 0 | api.fda.gov |
| Astura Medical | Irving, TX, United States | Complaint file establishment, Specification developer | 1 | March 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Blustone Synergy, LLC | Pueblo, CO, United States | Specification developer | 1 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Coligne AG | Zurich, Switzerland | Manufacturer | 1 | June 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| CarboFix Orthopedics, Ltd. | Herzeliya Central, Israel | Manufacturer | 1 | October 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | April 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Foundation Surgical Group | Scottsdale, AZ, United States | Complaint file establishment, Specification developer | 1 | November 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Holmed LLC | Attleboro, MA, United States | Contract manufacturer, Manufacturer | 1 | December 21, 2005 | 0 | 0 | 0 | api.fda.gov |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | October 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer | 1 | January 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Signature Orthopaedics Pty Limited | Sydney New South Wales, Australia | Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Spinevision SAS | Antony Hauts-de-Seine, France | Complaint file establishment, Manufacturer | 1 | December 28, 2004 | 0 | 0 | 0 | api.fda.gov |
| Signature Orthopaedics Europe Ltd | Athlone Westmeath, Ireland | Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | July 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | Manufacturer | 1 | December 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Ulrich Medical Usa, Inc. | Plano, TX, United States | Specification developer | 1 | November 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| United Orthopedic Corporation | Hsinchu Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Unified Spine, LLC | Westerville, OH, United States | Manufacturer, Specification developer | 1 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | December 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | December 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| 3D Systems - Layerwise | Heverlee Vlaams Brabant, Belgium | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| A.F.T. Micromecanique | Fillinges Haute-Savoie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Manufacturing And Engineering | Montgomeryville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anthogyr | SALLANCHES Haute-Savoie, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH - Quakertown | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components | Huntingdon Valley, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acero Precision | West Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Banister Tool, Inc. | Pflugerville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIEDERMANN MOTECH GMBH & Co. KG | VS-SCHWENNINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&A Tool Engineering, Inc. Auburn Plant | Auburn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Christian Diener GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coulot Decolletage | CHATELLERAULT Vienne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTL Biotec | Daegu, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fmi Medisch BV | Schiedam Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesys Spine | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gsell Medical Plastics AG | Muri Aargau, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hammill MFG. Co. | Maumee, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoosier, Inc. | Corona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jarvis Surgical Inc. | Westfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Grenchen) | Grenchen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Le Locle) | Le Locle Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Tuttlingen Manufacturing GmbH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lopitz Manufacturing | Gradignan Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Met One Technologies, LLC | El Paso, TX, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miing Wei Co., Ltd. | Tsao-Twon Nantou, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexxt Spine LLC | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ngage Medical Manufacturing | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odyssey Medical Technologies, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomni Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oury-Guye & Fils | NOGENT Haute-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PPD Meditech, Div. Of Industries PPD Inc. | Waterville Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precera Medical Neyron SAS | MIRIBEL CEDEX Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Forms, Inc. | Butler, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procon Medizintechnik GMBH | Alzenau Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies- North Manchester Manufacturing Facility | N Manchester, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Selenium Medical S.A.S. | La Rochelle Charente-Maritime, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sferic | MENARS Centre-Val de Loire, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Weigao Orthopaedic Device Co.,ltd | weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simagec | ROUSSET CEDEX Bouches-du-Rhone, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SINTX Technologies Inc. | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solco Biomedical Company India Private Limited | KADI Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Spine | CESTAS Nouvelle-Aquitaine, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangible Solutions, Inc. DBA Marle Tangible, Inc. | Fairborn, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech Industries. Inc. | Cleveland, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Orthopedic Corp. | Kaohsiung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vorzeigen | Connersville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vy Spine, LLC | Bountiful, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xcix Design, LLC | Richmond, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zigg Design LLC | Nibley, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.