510(k) Report

Devices descending from K033901

737 later devices reach Merlin Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191217Jazz PFImplanet, S.A.20190—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+6K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+6K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+6K103292Trio Trauma Spinal SystemStryker Corporation201185—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233300POWEReam 1/4 DriveStryker Instruments20231—
+7K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—