510(k) Report

Devices descending from K233508

5 later devices reach iFuse Bedrock Granite® Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+1K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+1K252322SIros-X SystemGenesys Spine20250—
+1K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+1K241464ARx® SAI Implant SystemLife Spine, Inc.20241—