510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K162206Zavation IBFZavation, LLC201724—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+5K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+5K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K141135Juliet LLSpineart2014146—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133126K7 Lumbar SpacersK7, LLC20131—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123969XiphosDifusion Technologies201314—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K121581Box Peek VBR System,Innovasis, Inc.20121—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K121176STGCCardinal Spine, LLC201259—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+5K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K120024Mectalif TransforaminalMedacta International S.A.201223—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K112664Zavation Ibf SystemsZavation, LLC201137—