510(k) Report

Devices descending from K063417

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230614Cortium™Ulrich Medical USA20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+4K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173508Everest Spinal SystemK2m20189—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162575Z-LINKPC SystemZavation, LLC20173—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141284Caspian Spinal SystemK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—