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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Si-Bone, Inc.Santa Clara, CA, United StatesManufacturer, Specification developer27February 11, 2026000api.fda.gov
Si-Bone, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer23February 11, 2026010api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer8August 24, 2026000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer5July 29, 2024000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer5March 25, 2021010api.fda.gov
Aegis Meditec, Inc.Costa Mesa, CA, United StatesSpecification developer3January 20, 2023000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer3September 21, 2023000api.fda.gov
Si-Technology, LLCWoodstock, GA, United StatesComplaint file establishment, Specification developer3June 6, 2025000api.fda.gov
Tenon Medical, Inc.Los Gatos, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3July 29, 2025000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer3March 21, 2023000api.fda.gov
Alevio, LLCCullman, AL, United StatesManufacturer2July 28, 2023000api.fda.gov
Biofusion MedicalAustin, TX, United StatesManufacturer2April 17, 2020000api.fda.gov
Cutting Edge SpineMineral Spgs, NC, United StatesRepackager or relabeler, Specification developer2June 24, 2022000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer2October 7, 2025000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer2October 22, 2025000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer2March 1, 2022000api.fda.gov
Promethean Restorative Inc.Castle Rock, CO, United StatesComplaint file establishment, Specification developer2April 25, 2025000api.fda.gov
Spinal Simplicity, LLCOverland Park, KS, United StatesComplaint file establishment, Specification developer2April 19, 2024000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer2August 12, 2016000api.fda.gov
Xenix MedicalOrlando, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2October 27, 2023000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer2March 25, 2014000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer1January 28, 2026000api.fda.gov
Advanced Research MedicalBurnsville, MN, United StatesManufacturer1January 22, 2021000api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer1October 3, 2022000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer1October 24, 2023000api.fda.gov
CAPTIVA SPINE, Inc.Jupiter, FL, United StatesComplaint file establishment, Specification developer1May 5, 2017000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1October 17, 2022000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesManufacturer1September 9, 2021000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer1August 31, 2021000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1August 26, 2005000api.fda.gov
Demetra, Inc.Hudson, MA, United StatesManufacturer1April 11, 2022000api.fda.gov
Foundation Fusion Solutions, LLCTulsa, OK, United StatesComplaint file establishment, Specification developer1July 27, 2022000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1February 6, 2019000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1February 6, 2019000api.fda.gov
Ilion Medical IncMinneapolis, MN, United StatesManufacturer1August 5, 2020000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer1May 29, 2012000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer1August 12, 2016000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1August 12, 2016000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer1March 14, 2025000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer1June 6, 2025000api.fda.gov
Si SolutionsColumbia, MO, United StatesSpecification developer1November 20, 2025000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer1September 28, 2023000api.fda.gov
VGI medical, LLCLargo, FL, United StatesManufacturer, Specification developer1March 29, 2023000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer1November 26, 2008000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer1November 26, 2008000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer1July 9, 2025000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
Ar FabricatingGeorgetown, TX, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Armadillo Additive, Inc.Granbury, TX, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Guardian Medical Usa, IncSwanton, OH, United StatesContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Oaktree AdditiveTampa, FL, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
PDV MedTechMorgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Pantheon Spinal LLCGeorgetown, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.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.