510(k) Report

Devices descending from K061162

131 later devices reach Bar Pedicle Screw Spinal Fixation System, Model 2020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—