510(k) Report

Devices descending from K211323

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223273ASTRA Spine SystemSpinecraft, LLC20228—
+1K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—