510(k) Report

Devices descending from K223273

8 later devices reach ASTRA Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+1K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+1K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+2K252322SIros-X SystemGenesys Spine20250—
+2K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+2K241464ARx® SAI Implant SystemLife Spine, Inc.20241—