510(k) Report

Devices descending from K223708

3 later devices reach Entasis 3D Dual-Lead Sacroiliac Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+1K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K250894Eminent Spine Posterior SI SystemEminent Spine20250—