510(k) Report

Devices descending from K083311

554 later devices reach Aesculap Cespace Peek Intervertebral Body Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+1K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+1K122588Vusion CS PlusOrtho Development Corp.2013206—
+1K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+1K112862Mecta-CMedacta International201114—
+1K110915Cervical CageEisertech, LLC201123—
+1K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+1K100889Endoskeleton TCTitan Spine, LLC2010455—
+2K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+2K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+2K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+2K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+2K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K122444Cervical CageEisertech, LLC201222—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K200429BEE CagesNGMedical GmbH202111—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200312Tryptik TiSpineart20202—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K1803473d CageFims Co., Ltd.20190—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K1421124WEB Spinal Implant Products4Web, Inc.201433—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—