510(k) Report

Devices descending from K060979

710 later devices reach Xia Titanium and 4.5 Spinal Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+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—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K183381Navigation Enabled InstrumentsStryker20191—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—