OUR
IFUSE IMPLANT SYSTEM
- Advisory panel
- Orthopedic
- Total cleared
- 131
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OUR
1–100 of 131- K260477 — CATAMARAN SI Joint Fusion System
- K253488 — iFuse INTRA Ti Implant System
- K253611 — Falco Fusion System
- K252834 — Sacroiliac Joint Truss System (SJTS)
- K251365 — OptumSI Implant System
- K252322 — SIros-X System
- K253094 — iFuse Bedrock Granite Implant System
- K250894 — Eminent Spine Posterior SI System
- K250647 — SImmetry+ System
- K250247 — panaSIa SI Fusion System
- K251395 — The Rialto SI Fusion System
- K242431 — Omnia Medical PsiF DNA System
- K251525 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K250001 — Patriot SI Implant System
- K251075 — DYNAMIS Implant System
- K250403 — Catamaran SI Joint Fusion System
- K243838 — NEXXT MATRIXX® SI System
- K243565 — DYNAMIS SI Screw System
- K243835 — TiLink-P SI Joint Fusion System
- K242414 — TiLink-P Joint Fusion System
- K242141 — TiLink-P SI Joint Fusion System
- K241504 — iFuse TORQ TNT Implant System
- K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K241464 — ARx® SAI Implant System
- K241574 — iFuse TORQ® Implant System
- K240505 — Eminent Spine SI Screw System
- K232149 — BowTie SI Joint Fusion System
- K232259 — Patriot-SI Posterior Implant System
- K240720 — TiLink-P SI Joint Fusion System
- K233972 — Camber Sacroiliac (SI) Fixation System
- K240201 — PathLoc SI Joint Fusion System
- K233508 — iFuse Bedrock Granite® Implant System
- K230817 — TORPEDO Implant System®
- K231923 — Liberty SI Lateral Implant System
- K233241 — SOLACE Sacroiliac Fixation System
- K232211 — REUNION Sacroiliac Joint Fusion System
- K232878 — TransLoc 3D
- K232605 — Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
- K230857 — TiLink-P SI Joint Fusion System
- K230226 — Integrity-SI® Fusion System
- K231944 — CATAMARAN SI Joint Fusion System
- K231829 — Xenix Medical Sacroiliac Fixation System
- K231831 — TiLink-L Joint Fusion System
- K231951 — SI-Cure Sacroiliac Joint Fusion System
- K231841 — PathLoc SI Joint Fusion System
- K231689 — iFuse TORQ® Implant System
- K230446 — TiLink-L SI Joint Fusion System
- K220274 — Kisar Stratford SI Screw System
- K230689 — T-FIX 3DSI Joint Fusion System
- K213815 — SiJoin®T3
- K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System
- K223521 — ZESPIN SI Joint Fusion System
- K223819 — SI-Cure Sacroiliac Joint Fusion System
- K222774 — iFuse Bedrock Granite® Implant System
- K211785 — CASSATT SIJ Fixation System
- K222448 — UNITY Sacroiliac Joint Fixation System
- K221047 — SILO TFX MIS Sacroiliac Joint Fixation System
- K222605 — iFuse TORQ® Implant System
- K222512 — Integrity-SI Fusion System
- K203503 — Camber Sacroiliac (SI) Fixation System
- K211496 — TransLoc 3D
- K221050 — ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
- K214123 — T-FIX® 3DSI Joint Fusion System
- K213667 — iFuse-TORQ® Implant System
- K220195 — iFuse Bedrock Granite Implant System
- K212962 — TRELLIS SI Joint Fusion System
- K213590 — Blue Topaz Sacroiliac Screw System
- K212903 — SIMPACT Sacroiliac Joint Fixation System
- K210402 — Curiteva Sacroiliac Joint Fusion System
- K211449 — Triton Sacroiliac Joint Fixation System
- K210667 — FIREBIRD SI Fusion System
- K203780 — Harvester SI: Sacroiliac Fixation System
- K203247 — iFuse-TORQ Implant System
- K210035 — ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
- K203373 — Advanced Research Medical Trident SI Screw System
- K203671 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K203138 — FIREBIRD SI Fusion System
- K201538 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K201664 — FIREBIRD SI Fusion System
- K190580 — NADIA SI Fusion System
- K200868 — SI-Restore Sacroiliac Joint Fixation System
- K200696 — FIREBIRD SI Fusion System
- K193524 — SI-BONE iFuse Implant System®
- K193083 — M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
- K191748 — Genesys Spine Sacroiliac Joint Fusion System
- K190025 — EVOL® -SI Joint Fusion System
- K183342 — SambaScrew 3D SI Fusion System
- K190230 — iFuse Implant System®
- K183119 — SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
- K182919 — SI-Restore® Sacroiliac Joint Fixation System
- K182983 — iFuse Implant System®
- K181881 — Outlet Sacroiliac Joint Fusion System
- K181600 — PathLoc-SI Joint Fusion System
- K180749 — Life Spine SIMPACT Sacroiliac Joint Fixation System
- K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
- K173201 — UNITY Sacroiliac Joint Fixation System
- K173752 — SI Screw System
- K171595 — M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
- K170475 — SICAGE System
- K162733 — iFuse Implant System® - iFuse-3D implant
Data sourced from openFDA. This site is unofficial and independent of the FDA.