510(k) Report

Devices descending from K083857

902 later devices reach LDR Spine Roi-C Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221578Hexanium ACIFSpinevision, S.A.S.20224—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+4K211413BEE PLIF CageNGMedical GmbH20211—
+4K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K200429BEE CagesNGMedical GmbH202111—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K200312Tryptik TiSpineart20202—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K1803473d CageFims Co., Ltd.20190—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K190380nvcNvision Biomedical Technologies, Inc.20193—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K181397DualXInnovasive, Inc.201815—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K173893TrabisColigne AG20180—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—