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Panels › Orthopedic › Product code OUR · Class 2

Sacroiliac Joint Fixation

Regulation 888.3040

7510(k)s in 12 months (133 all time)
2recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in OUR

Company510(k)sRecalls
SI-BONE, Inc.271
SurGenTec, LLC80
Zyga Technology, Inc.60
Life Spine, Inc.50
Orthofix, Inc.50
L&K BIOMED Co., Ltd.40
Tenon Medical40
Aegis Spine30
Camber Spine Technologies30
Cutting Edge Spine, LLC30
Decided510(k)Device and applicantCode
Oct 15, 2026K262522Odys-SI Screw
Medyssey Co, Ltd., KR
OUR
Aug 24, 2026K261381TiLink-L™ SI Joint Fusion System
SurGenTec, LLC
OUR
Apr 8, 2026K260477CATAMARAN™ SI Joint Fusion System
Tenon Medical
OUR
Feb 11, 2026K253488iFuse INTRA Ti™ Implant System
SI-BONE, Inc.
OUR
Jan 29, 2026K253611Falco Fusion System
Mcnicoll Surgical, Inc., CA
OUR
Jan 28, 2026K252834Sacroiliac Joint Truss System (SJTS)
4Web Medical
OUR
Nov 20, 2025K251365OptumSI Implant System
Si Solutions, LLC
OUR
Oct 22, 2025K252322SIros-X System
Genesys Spine
OUR
Oct 9, 2025K253094iFuse Bedrock Granite Implant System
SI-BONE, Inc.
OUR
Oct 7, 2025K250894Eminent Spine Posterior SI System
Eminent Spine
OUR
Jul 29, 2025K250647SImmetry+ System
Sivantage
OUR
Jul 9, 2025K250247panaSIa SI Fusion System
Wenzel Spine, Inc.
OUR
Jun 26, 2025K251395The Rialto™ SI Fusion System
Medtronic Sofamor Danek USA, Inc.
OUR
Jun 6, 2025K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Si-Technology, LLC
OUR
Jun 6, 2025K242431Omnia Medical PsiF DNA™ System
Omnia Medical, LLC
OUR
Jun 3, 2025K250001Patriot SI Implant System
Spinal Simplicity, LLC
OUR
Apr 25, 2025K251075DYNAMIS™ Implant System
Promethean Restorative, LLC
OUR
Mar 21, 2025K250403Catamaran SI Joint Fusion System
Tenon Medical
OUR
Mar 14, 2025K243838NEXXT MATRIXX® SI System
Nexxt Spine
OUR
Feb 28, 2025K243565DYNAMIS™ SI Screw System
Promethean Restorative, LLC
OUR
Dec 27, 2024K243835TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Nov 21, 2024K242414TiLink-P Joint Fusion System
SurGenTec, LLC
OUR
Aug 21, 2024K242141TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Aug 19, 2024K241504iFuse TORQ TNT™ Implant System
SI-BONE, Inc.
OUR
Aug 13, 2024K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Si-Technology, LLC
OUR
Jul 29, 2024K241464ARx® SAI Implant System
Life Spine, Inc.
OUR
Jul 2, 2024K241574iFuse TORQ® Implant System
SI-BONE, Inc.
OUR
Jun 4, 2024K240505Eminent Spine SI Screw System
Eminent Spine, LLC
OUR
Apr 20, 2024K232149BowTie™ SI Joint Fusion System
Sail Fusion, LLC
OUR
Apr 19, 2024K232259Patriot-SI Posterior Implant System
Spinal Simplicity, LLC
OUR
Apr 11, 2024K240720TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Feb 27, 2024K233972Camber Sacroiliac (SI) Fixation System
Camber Spine Technologies
OUR
Feb 23, 2024K240201PathLoc SI Joint Fusion System
L&K BIOMED Co., Ltd., KR
OUR
Jan 26, 2024K233508iFuse Bedrock Granite® Implant System
SI-BONE, Inc.
OUR
Jan 19, 2024K230817TORPEDO Implant System®
Deltacor GmbH, DE
OUR
Dec 5, 2023K231923Liberty SI Lateral Implant System
Spinal Simplicity, LLC
OUR
Oct 27, 2023K233241SOLACE Sacroiliac Fixation System
Ht Medical, LLC Dba Xenix Medical
OUR
Oct 24, 2023K232211REUNION Sacroiliac Joint Fusion System
Astura Medical
OUR
Oct 17, 2023K232878TransLoc 3D
Foundation Fusion Solutions, LLC (Dba Cornerloc)
OUR
Sep 28, 2023K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervic
Lesspine Innovations
OUR
Sep 25, 2023K230857TiLink-P SI Joint Fusion System
SurGenTec, LLC
OUR
Sep 21, 2023K230226Integrity-SI® Fusion System
OsteoCentric Technologies
OUR
Aug 24, 2023K231944CATAMARAN SI Joint Fusion System
Tenon Medical, Inc.
OUR
Aug 15, 2023K231829Xenix Medical Sacroiliac Fixation System
Ht Medical D.B.A. Xenix Medical
OUR
Aug 3, 2023K231831TiLink-L Joint Fusion System
Surgentec
OUR
Jul 28, 2023K231951SI-Cure Sacroiliac Joint Fusion System
Alevio, LLC
OUR
Jul 14, 2023K231841PathLoc SI Joint Fusion System
L&K BIOMED Co., Ltd., KR
OUR
Jun 30, 2023K231689iFuse TORQ® Implant System
SI-BONE, Inc.
OUR
Jun 7, 2023K230446TiLink-L SI Joint Fusion System
SurGenTec, LLC
OUR
Apr 24, 2023K220274Kisar Stratford SI Screw System
Anjali Investments L.L.C
OUR

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