510(k) Report

Devices descending from K073285

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212358Romero Cervical CageSpineup, Inc.20226—
+3K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K203444BEE HA CageNGMedical GmbH20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K171312FortiCore®Nanovis, LLC20183—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151939COALITION SpacersGlobus Medical, Inc.2016152—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+3K140280ForticoreNanovis, LLC20149—
+3K141005Z-Link CervicalZavation, LLC20144—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K263049SABER-C SystemElevation Spine20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—