510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162206Zavation IBFZavation, LLC201724—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+4K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K140348Interbody CageEisertech, LLC2015235—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142328nvcNvision Biomedical Technologies, LLC20144—
+4K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+4K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+4K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+4K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+4K141337Arena-CSpinefrontier, Inc.20141—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K133802Ais Modulift VBR SystemAesculap Implant System, Inc.201448—
+4K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+4K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+4K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+4K121178Transcorp Acif SystemTranscorp, Inc.20130—
+4K131372Mobis IISignus Medizintechnik GmbH2013462—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K124034Mectalif AnteriorMedacta International201311—
+4K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K123969XiphosDifusion Technologies201314—
+4K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+4K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+4K120401Alamo TAlliance Partners, LLC20121—
+4K122444Cervical CageEisertech, LLC201222—
+4K121176STGCCardinal Spine, LLC201259—
+4K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+4K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+4K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+4K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+4K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+4K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+4K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K120576Zavation Ibf SystemZavation, LLC201232—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+4K112493Pass LP Spinal SystemMedicrea International20111—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K112359Prow FusionNlt Spine, Ltd.2011601—
+4K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+4K111965Vusion (R) OSOrtho Development20110—
+4K111484DiscoveryIntuitive Spine, LLC20111—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—