510(k) Report

Devices descending from K152237

11 later devices reach The Entasis Dual-Lead Sacroiliac Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+1K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+1K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+1K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+1K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+2K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—