510(k) Report

Devices descending from K031655

1,220 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+7K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+7K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+7K113346Neon SystemUlrich GmbH & Co. KG20121—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K230614Cortium™Ulrich Medical USA20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K201585Monterey AL Interbody SystemStryker Corporation202044
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+8K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+9K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+9K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+9K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—