510(k) Report

Devices descending from K003836

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173508Everest Spinal SystemK2m20189—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K172065Scarlet AC-TSpineart20172—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K162587Roccia® AcifSilony Medical GmbH20171—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+6K153621Juliet® TiSpineart2016751
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K160125Cascadia Interbody SystemK2m2016315—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+6K142487Chesapeake Stabilization SystemK2m, Inc.201571
+6K142744Mecta-C TiPEEKMedacta International201512—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K142277Juliet POSpineart2014119—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—