510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+7K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200312Tryptik TiSpineart20202—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191134IB3D AlifMedicrea International SA20191—
+7K1803473d CageFims Co., Ltd.20190—
+7K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K190380nvcNvision Biomedical Technologies, Inc.20193—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181397DualXInnovasive, Inc.201815—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181337Sypher Spacer SystemBiogennix, LLC20180—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+7K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+7K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+7K172480icotec Interbody Cage SystemIcotec AG20185—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K171312FortiCore®Nanovis, LLC20183—
+7K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172424Velofix™ SA Cervical CageU&I Corporation201751
+7K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+7K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+7K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+7K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+7K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+7K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+7K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+7K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—