510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+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—
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K160640PASS XS Spinal SystemMedicrea International SA20160—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+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—
+7K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., 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—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+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—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+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—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K230614Cortium™Ulrich Medical USA20230—
+8K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+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—
+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—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+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—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+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—
+8K131833Centurion Poct SystemOrthofix, Inc.20142—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+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—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—