510(k) Report

Devices descending from K032265

1,192 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+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—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+7K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+7K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+7K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+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—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+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—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+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—
+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—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+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—
+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—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+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—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+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—