510(k) Report

Devices descending from K033702

1,036 later devices reach Blackstone Peek Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200312Tryptik TiSpineart20202—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K191796Neo Cage SystemNeo Medical SA20190—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K1803473d CageFims Co., Ltd.20190—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K181048Neo Cage System TMNeo Medical SA20191—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181818Scarlet AL-TSpineart201864—
+7K181397DualXInnovasive, Inc.201815—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+7K181337Sypher Spacer SystemBiogennix, LLC20180—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K181203Juliet TiSpineart20181—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K172480icotec Interbody Cage SystemIcotec AG20185—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171425Concorde LiftMedos International SARL201782
+7K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K162206Zavation IBFZavation, LLC201724—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K153436LATERAL Spine Truss System4Web, Inc.20165—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+7K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101