510(k) Report

Devices descending from K073285

637 later devices reach Peek Prevail Cervical Interbody Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+1K162531Sterispine CCSafe Orthopaedics20160—
+1K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+1K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+1K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+1K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+1K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+1K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+1K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+1K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+1K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+1K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+1K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+2K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+2K250769Dakota LP SystemPrecision Spine, Inc.20250—
+2K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+2K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K172065Scarlet AC-TSpineart20172—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+2K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+2K130853Idys (TM) CClariance20132—
+2K131449Coalition SpacerGlobus Medical, Inc.2013235—
+2K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+2K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+2K112388Lanx Cervical SALanx, Inc.201126—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+3K250560BEE HANGMedical GmbH20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+3K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—