Data / Medical devices / Sacroiliac Joint Fixation / United States
FDA-registered makers of Sacroiliac Joint Fixation in the United States: 118 establishments
118 establishments in the United States are registered with the FDA to make Sacroiliac Joint Fixation (product code OUR). 46 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Sacroiliac Joint Fixation
- Product code
- OUR
- Country
- United States
Makers of Sacroiliac Joint Fixation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Si-Bone, Inc. | Santa Clara, CA, United States | Manufacturer, Specification developer | 27 | February 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Si-Bone, Inc. | Santa Clara, CA, United States | Complaint file establishment, Specification developer | 23 | February 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| Surgentec LLC | Boca Raton, FL, United States | Manufacturer | 8 | August 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 5 | July 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | March 25, 2021 | 0 | 1 | 0 | api.fda.gov |
| Aegis Meditec, Inc. | Costa Mesa, CA, United States | Specification developer | 3 | January 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| OsteoCentric Technologies,Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 3 | September 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Si-Technology, LLC | Woodstock, GA, United States | Complaint file establishment, Specification developer | 3 | June 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tenon Medical, Inc. | Los Gatos, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | July 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | March 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Alevio, LLC | Cullman, AL, United States | Manufacturer | 2 | July 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biofusion Medical | Austin, TX, United States | Manufacturer | 2 | April 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cutting Edge Spine | Mineral Spgs, NC, United States | Repackager or relabeler, Specification developer | 2 | June 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 2 | October 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Genesys Spine | Austin, TX, United States | Manufacturer | 2 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osseus Fusion Systems LLC | Dallas, TX, United States | Repackager or relabeler, Specification developer | 2 | March 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Promethean Restorative Inc. | Castle Rock, CO, United States | Complaint file establishment, Specification developer | 2 | April 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Spinal Simplicity, LLC | Overland Park, KS, United States | Complaint file establishment, Specification developer | 2 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 2 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Xenix Medical | Orlando, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Repackager or relabeler, Specification developer | 2 | March 25, 2014 | 0 | 0 | 0 | api.fda.gov |
| 4web Inc. | Frisco, TX, United States | Specification developer | 1 | January 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Advanced Research Medical | Burnsville, MN, United States | Manufacturer | 1 | January 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aurora Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 1 | October 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Astura Medical | Irving, TX, United States | Complaint file establishment, Specification developer | 1 | October 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| CAPTIVA SPINE, Inc. | Jupiter, FL, United States | Complaint file establishment, Specification developer | 1 | May 5, 2017 | 0 | 0 | 0 | api.fda.gov |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Curiteva, Inc. | Tanner, AL, United States | Manufacturer | 1 | September 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Choice Spine LLC | Knoxville, TN, United States | Complaint file establishment, Specification developer | 1 | August 31, 2021 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 1 | August 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| Demetra, Inc. | Hudson, MA, United States | Manufacturer | 1 | April 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Foundation Fusion Solutions, LLC | Tulsa, OK, United States | Complaint file establishment, Specification developer | 1 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | February 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 1 | February 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ilion Medical Inc | Minneapolis, MN, United States | Manufacturer | 1 | August 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 1 | May 29, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | August 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nexxt Spine LLC | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 1 | June 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Si Solutions | Columbia, MO, United States | Specification developer | 1 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer | 1 | September 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| VGI medical, LLC | Largo, FL, United States | Manufacturer, Specification developer | 1 | March 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 1 | November 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 1 | November 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Wenzel Spine | Austin, TX, United States | Specification developer | 1 | July 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | 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 | |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | 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 | |
| Aps Materials, Inc. | Dayton, OH, 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 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 - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armadillo Additive, Inc. | Granbury, TX, 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 | |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Additive / Slice Manufacturing Studios | Akron, OH, 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 | |
| Bioseal | Placentia, CA, 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 | |
| Culver Tool & Engineering | Plymouth, IN, 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 | |
| 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 | |
| Geotec, Inc. | Warwick, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardian Medical Usa, Inc | Swanton, OH, 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 | |
| Himed, LLC | Old Bethpage, NY, 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 | |
| J & J Precision Technologies, LLC | Lititz, PA, 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. (Monument) | Monument, CO, United States | Contract manufacturer | 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 | |
| Mainstream Medical Devices | Austin, TX, United States | Contract 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 | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maestro Logistics, LLC | Austin, TX, 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 | |
| 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 | |
| Oaktree Additive | Tampa, FL, 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 | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, 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 | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, 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 | |
| Quality Tech Services, LLC | Bloomington, MN, 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 | |
| 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 | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOMZ Corporation | Berlin, CT, 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 | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | 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 | |
| Watershed Idea Foundry, Inc. | Carlsbad, CA, 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 |
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.