510(k) Report

Devices descending from K061441

261 later devices reach Ebi 5.5 Helical Flange Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K190376PASS LP Spinal SystemMedicrea International SA201915
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—