510(k) Report

Devices descending from K933881

796 later devices reach Depuy Motech Moss-Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K090320Conquest Spinal SystemLife Spine20092—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+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—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K230026SqualeImplanet, S.A.20230—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K183381Navigation Enabled InstrumentsStryker20191—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—