510(k) Report

Devices descending from K062083

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+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—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K163180Hubble IIOrbbo Surgical, LLC20160—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K153436LATERAL Spine Truss System4Web, Inc.20165—
+5K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+5K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+5K152304Tritanium PL CageStryker20154481
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+5K133717Longbow Spacer SystemLife Spine20149—
+5K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133192Mectalif TipeekMedacta International201416—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130445Vault Alif SystemSpinal USA20139—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+5K110226Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201190—
+5K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+6K263049SABER-C SystemElevation Spine20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—