510(k) Report

Devices descending from K060762

789 later devices reach Aesculap Peek Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+1K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+1K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+2K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+2K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113478Plif CageEisertech, LLC2012269—
+2K112862Mecta-CMedacta International201114—
+2K110915Cervical CageEisertech, LLC201123—
+2K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+2K100889Endoskeleton TCTitan Spine, LLC2010455—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K1803473d CageFims Co., Ltd.20190—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K140348Interbody CageEisertech, LLC2015235—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+3K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+3K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+3K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+3K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K131178Idys Lif CagesClariance201311—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+3K122444Cervical CageEisertech, LLC201222—
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+4K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243670Idys® LIFClariance20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K200429BEE CagesNGMedical GmbH202111—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—