510(k) Report

Devices descending from K000094

988 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K150918PASS OCT Spinal SystemMedicrea International SA201513—
+7K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+7K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K120998Solstice Cross ConnectorLife Spine20121—
+7K113058Tiger Spine SystemCorelink, LLC201281—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+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—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—