510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172941CASCADIA Interbody SystemK2m201852—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K162367Erisma® LP MISClariance, Sas20162—
+6K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+6K160362Z-Span Plate SystemZavation, LLC20163—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+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—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, 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—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+7K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+7K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162824Z-Span Plate SystemZavation, LLC20172—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—