510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173702Juliet Ti LLSpineart20182—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K172065Scarlet AC-TSpineart20172—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K141791Biomet Fusion SystemBiomet Spine2014128—
+4K140280ForticoreNanovis, LLC20149—
+4K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+4K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K131449Coalition SpacerGlobus Medical, Inc.2013235—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K131547Lanx Fusion SystemLanx, Inc.20131631
+4K131671MectalifMedacta International201322—
+4K131372Mobis IISignus Medizintechnik GmbH2013462—
+4K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+4K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+4K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—