510(k) Report

Devices descending from K212903

8 later devices reach SIMPACT Sacroiliac Joint Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+1K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+1K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+2K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—