510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K120998Solstice Cross ConnectorLife Spine20121—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250637VCFix Spinal SystemAmber Implants20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+8K161149PASS OCT Spinal SystemMedicrea International SA20160—
+8K160756PASS OCT Spinal SystemMedicrea International SA20160—
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K153169PASS OCT Patient Specific RodsMedicrea International20164—
+8K152211PCT SystemCentinel Spine, Inc.20150—
+8K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+8K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K223326Axiom PSR SystemRestor3D202301