Data / Medical devices / Appliance, Fixation, Spinal Intervertebral Body / United States
FDA-registered makers of Appliance, Fixation, Spinal Intervertebral Body in the United States: 218 establishments
218 establishments in the United States are registered with the FDA to make Appliance, Fixation, Spinal Intervertebral Body (product code KWQ). 76 have a 510(k) clearance or PMA approval on file and 13 have a recall event. FDA data exported November 3, 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.
- Device
- Appliance, Fixation, Spinal Intervertebral Body
- Product code
- KWQ
- Country
- United States
Makers of Appliance, Fixation, Spinal Intervertebral Body in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Repackager or relabeler, Specification developer | 32 | November 12, 2015 | 0 | 4 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 31 | October 8, 2020 | 0 | 3 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 31 | November 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 30 | September 6, 2013 | 0 | 2 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 27 | November 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 27 | November 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 25 | December 2, 2015 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 23 | November 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 19 | February 11, 2022 | 0 | 1 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Complaint file establishment, Manufacturer, Specification developer | 18 | November 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics | Bridgewater, MA, United States | Manufacturer, Repackager or relabeler | 16 | September 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 15 | June 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 14 | January 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 13 | November 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 12 | September 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 12 | November 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 11 | August 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | November 7, 2024 | 0 | 4 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 9 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 9 | March 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 8 | August 28, 2025 | 0 | 4 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 7 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Choice Spine LLC | Knoxville, TN, United States | Complaint file establishment, Specification developer | 6 | May 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Genesys Spine | Austin, TX, United States | Manufacturer | 6 | October 24, 2019 | 0 | 1 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 5 | November 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| TranS1 | Magnolia, TX, United States | Complaint file establishment, Specification developer | 5 | November 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | January 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 4 | August 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Evolution Spine, LLC | Dallas, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 4 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 4 | April 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nexxt Spine LLC | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 4 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Altus Partners | West Chester, PA, United States | Repackager or relabeler, Specification developer | 3 | May 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Carlsmed, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 3 | September 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Curiteva, Inc. | Tanner, AL, United States | Contract manufacturer, Manufacturer | 3 | February 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Degen Medical | Florence, SC, United States | Complaint file establishment, Specification developer | 3 | January 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| INNO Holdings Inc. | Millcreek, UT, United States | Manufacturer | 3 | November 8, 2019 | 0 | 2 | 0 | api.fda.gov |
| Mirus, LLC | Marietta, GA, United States | Manufacturer | 3 | May 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nexus Spine, L.L.C. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 3 | February 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nexus Spine, LLC. | Lehi, UT, United States | Specification developer | 3 | February 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Repackager or relabeler, Specification developer | 3 | October 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spinecraft LLC | Westmont, IL, United States | Manufacturer, Specification developer | 3 | March 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vy Spine, LLC | Bountiful, UT, United States | Manufacturer, Specification developer | 3 | March 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| 4web Inc. | Frisco, TX, United States | Specification developer | 2 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Atlas Spine Inc. | Jupiter, FL, United States | Manufacturer | 2 | November 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Camber Spine Technologies | King of Prussia, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | April 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| CAPTIVA SPINE, Inc. | Jupiter, FL, United States | Complaint file establishment, Specification developer | 2 | June 11, 2015 | 0 | 2 | 0 | api.fda.gov |
| Kalitec Direct LLC DBA Kalitec Medical | Sarasota, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | September 22, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nanovis Spine, LLC | Columbia City, IN, United States | Manufacturer, Specification developer | 2 | October 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Paramount Surgicals, Inc. | Brownsville, TX, United States | Repackager or relabeler, Specification developer | 2 | April 16, 2007 | 0 | 0 | 0 | api.fda.gov |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer, Manufacturer | 2 | June 20, 2023 | 0 | 1 | 0 | api.fda.gov |
| Precision Medical Technologies- North Manchester Manufacturing Facility | N Manchester, IN, United States | Manufacturer | 2 | January 19, 2010 | 0 | 0 | 0 | api.fda.gov |
| Southern Spine, LLC | Macon, GA, United States | Specification developer | 2 | May 16, 2007 | 0 | 0 | 0 | api.fda.gov |
| Teslake, Inc. | San Diego, CA, United States | Specification developer | 2 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ulrich Medical Usa, Inc. | Plano, TX, United States | Specification developer | 2 | March 18, 2024 | 0 | 1 | 0 | api.fda.gov |
| UOC USA Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 2 | February 18, 2000 | 0 | 0 | 0 | api.fda.gov |
| Aegis Meditec, Inc. | Costa Mesa, CA, United States | Specification developer | 1 | January 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Escondido LLC | Escondido, CA, United States | Manufacturer | 1 | July 21, 2010 | 0 | 0 | 0 | api.fda.gov |
| Aurora Spine, Inc. | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 1 | March 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Astura Medical | Irving, TX, United States | Complaint file establishment, Specification developer | 1 | August 23, 2016 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | December 22, 2009 | 0 | 0 | 0 | api.fda.gov |
| Expanding Innovations, Inc. | Mountain View, CA, United States | Complaint file establishment, Manufacturer | 1 | May 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Flospine LLC | Boca Raton, FL, United States | Manufacturer | 1 | April 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| G Surgical LLC | Austin, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | January 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Met One Technologies, LLC | El Paso, TX, United States | Manufacturer, Specification developer | 1 | December 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medynus, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Ortho Development Corp. | Draper, UT, United States | Complaint file establishment, Manufacturer | 1 | April 5, 2002 | 0 | 0 | 0 | api.fda.gov |
| Osseus Fusion Systems LLC | Dallas, TX, United States | Repackager or relabeler, Specification developer | 1 | April 26, 2016 | 0 | 0 | 0 | api.fda.gov |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 1 | December 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Rhausler, Inc. | Fremont, CA, United States | Specification developer | 1 | February 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| RSB Spine LLC. | Wooster, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | October 6, 2009 | 0 | 0 | 0 | api.fda.gov |
| Spinal Simplicity, LLC | Overland Park, KS, United States | Complaint file establishment, Specification developer | 1 | May 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| SpineNet LLC | Maitland, FL, United States | Specification developer | 1 | February 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | July 14, 2008 | 0 | 0 | 0 | api.fda.gov |
| Unified Spine, LLC | Westerville, OH, United States | Manufacturer, Specification developer | 1 | July 25, 2011 | 0 | 0 | 0 | api.fda.gov |
| Valorus Spine, LLC | Danville, CA, United States | Manufacturer | 1 | October 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Xenco Medical LLC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alden Tool Company, Inc. | Berlin, CT, United States | 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 | |
| Ar Fabricating | Georgetown, TX, 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 | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH-MedTorque | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Plymouth, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, 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 | |
| B & J Medical LLC | Kendallville, IN, 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 | |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | 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 | |
| Cep Bio-Coat, LLC | Farmington Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Wire Cut Company, Inc. | Valencia, CA, United States | 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 | |
| Donatelle Plastics, LLC | New Brighton, MN, 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 | |
| Elevation Spine | Monterey, CA, United States | Specification developer | 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 | Florence, AL, 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 | |
| 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 | |
| Fort Wayne Metals Research Products, LLC | Fort Wayne, IN, United States | 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 | |
| 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 | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | 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 & J Precision Technologies, LLC | Lititz, PA, 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 | |
| LH Medical Corporation | Fort Wayne, IN, United States | 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 | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | 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 | |
| Mach Medical | Columbia City, IN, 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 | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Component Specialists | Bellingham, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Device And Implants LLC | Lancaster, PA, 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 | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 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 | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Machining Midtown LLC | Atlanta, GA, 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 | |
| Ngage Medical Manufacturing | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, 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 | |
| Norwood Medical LLC | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novus Manufacturing Solutions | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | 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 | |
| P&F Machining | Otsego, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Instruments Inc. | Honolulu, HI, 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 | |
| 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 | |
| Precision Medical Technologies | Rome City, IN, United States | 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 | |
| Pantheon Spinal LLC | Georgetown, TX, United States | Complaint file establishment, Specification developer | 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 | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, 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 | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RevZero, Inc. | Chanhassen, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Stoll Metalcraft, Inc. | Santa Clarita, CA, United States | 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 | |
| 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, Inc. - Manchester | Manchester, NH, United States | 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 | |
| Summit Orthopedic Technologies Inc. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T & L Sharpening, Inc. | Indiana Beach, IN, 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 | |
| Troy Innovative Instruments Co LLC | Middlefield, OH, 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 | |
| Tech Industries. Inc. | Cleveland, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecomet, Inc. | Wilmington, MA, 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 | |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | 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 | |
| Viant AS&O Holdings, LLC | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Orchard Park, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westwood Precision LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watershed Idea Foundry, Inc. | Carlsbad, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenix Medical | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 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 November 3, 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.