510(k) Report

Devices descending from K042025

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K153413PASS LP Spinal SystemMedicrea International SA20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+6K140734Nextgen Altius Oct SystemEbi, LLC20140—
+6K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+6K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+6K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K113058Tiger Spine SystemCorelink, LLC201281—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K230614Cortium™Ulrich Medical USA20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133