510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142205NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc.201574—
+1K103320Synthes XRLSynthes Spine Co.Lp201131
+1K083186Aesculap Hydrolift VBR SystemAesculap Implant System, Inc.201051—
+1K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+1K070082XY Cor Spinal Implant for Minimal Invasive Spinal SurgeryVertebration,Inc2007641—
+1K061891Synex IISynthes Spine Co.Lp200677—
+1K060506Stryker Spine Vlift Vertebral Body Replacement SystemStryker Spine2006270—
+1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+1K032064Theken Cpod/Lpod Vertebral Body Replacement SystemTheken Surgical,Llc20041,2801
+2K261031Poseidon STSignus Medinzintechnik GmbH20260—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+2K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+2K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.20190—
+2K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+2K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+2K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+2K152460Rectangular Corpectomy CageAmendia, Inc.20150—
+2K151651NuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, Incorporated201568—
+2K151538NuVasive PEEK Corpectomy Railed SystemNu Vasive, Incorporated201513—
+2K151167NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated201513—
+2K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+2K110153SFC Vertebral Body ReplacementKonigsee Implantate GmbH20110—
+2K112756Fortify (TM) and Fortify (TM)-R Corpectomy SpacersGlobus Medical, Inc.2011268—
+2K091946Vlift-S Vertebral Body Replacement System, Models 488812XX, 488814XX, 488816XX, 488818XXStryker Spine20095—
+2K090566Pathway AvidCustom Spine, Inc.2009639—
+2K082466Xycor Spinal ImplantVertebration,Inc200942—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+2K072326Ostapek VBR SystemCo-Ligne AG20081—
+2K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+2K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+2K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+2K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+2K043479MC+ Partial VBRLdr Spine USA20051,214—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+3K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+3K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+3K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+3K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated201811—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+3K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+3K173893TrabisColigne AG20180—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+3K172323Omnia Medical VBROmnia Medical, LLC20176—
+3K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+3K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+3K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K153400ProLift Expandable SystemLife Spine, Inc.201672—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K132718Integrity Spine Core SystemIntegrity Spine20131—
+3K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+3K123969XiphosDifusion Technologies201314—
+3K123388K7C SpacerK7, LLC20130—
+3K121581Box Peek VBR System,Innovasis, Inc.20121—
+3K121107Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R)Globus Medical, Inc.2012214—
+3K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+3K111726Pathway AvidCustom Spine, Inc.201295—
+3K111294Santorini Spinal SystemK2m, Inc.201218—
+3K112493Pass LP Spinal SystemMedicrea International20111—
+3K112359Prow FusionNlt Spine, Ltd.2011601—
+3K111965Vusion (R) OSOrtho Development20110—
+3K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+3K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+3K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—