510(k) Report

Devices descending from K020152

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+6K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+6K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+6K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+6K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+6K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+6K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+6K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+6K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+6K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+6K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+6K150847Foundation Interbody DevicesCorelink, LLC201529—
+6K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+6K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+6K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+6K141798Sypher Spacer SystemBiogennix, LLC20151—
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+6K142328nvcNvision Biomedical Technologies, LLC20144—
+6K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+6K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+6K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+6K141337Arena-CSpinefrontier, Inc.20141—
+6K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+6K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+6K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+6K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+6K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+6K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+6K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+6K133967Interbody Cage SystemAurora Spine2014227—
+6K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+6K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+6K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+6K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+6K133126K7 Lumbar SpacersK7, LLC20131—
+6K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+6K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+6K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+6K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+6K131077Life Spine Plateau Spacer SystemLife Spine201310—
+6K121178Transcorp Acif SystemTranscorp, Inc.20130—
+6K131372Mobis IISignus Medizintechnik GmbH2013462—
+6K122588Vusion CS PlusOrtho Development Corp.2013206—
+6K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+6K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+6K123969XiphosDifusion Technologies201314—
+6K123134Easyspine SystemLdr Spine USA, Inc.20131—
+6K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+6K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+6K120401Alamo TAlliance Partners, LLC20121—
+6K122444Cervical CageEisertech, LLC201222—
+6K121176STGCCardinal Spine, LLC201259—
+6K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+6K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+6K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+6K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+6K121116Plateau Spacer SystemLife Spine201213—
+6K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K120576Zavation Ibf SystemZavation, LLC201232—
+6K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+6K113478Plif CageEisertech, LLC2012269—
+6K120024Mectalif TransforaminalMedacta International S.A.201223—
+6K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+6K113138Aleutian SystemK2m, Inc.2012549—
+6K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+6K112664Zavation Ibf SystemsZavation, LLC201137—
+6K112862Mecta-CMedacta International201114—
+6K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+6K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+6K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+6K111484DiscoveryIntuitive Spine, LLC20111—
+6K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+6K110915Cervical CageEisertech, LLC201123—
+6K110843Aleutian Spacer SystemK2m, Inc.2011589—
+6K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+6K110177Helena SystemRoyal Oak Medical Devices20110—
+6K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+6K103666Lanx LateralLanx, Inc.2011238—
+6K100698STCCCardinal Spine, LLC2011346—
+6K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+6K102738Lanx Fusion SystemLanx, LLC20113281
+6K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—