510(k) Report

Devices descending from K121630

127 later devices reach Range Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—