510(k) Report

Devices descending from K120291

138 later devices reach OP Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K190751Connector SystemOrthofix, Inc.20193—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—