510(k) Report

Devices descending from K993810

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173508Everest Spinal SystemK2m20189—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K142360Everest Spinal SystemK2m, Inc.201522—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K151216Everest Spinal SystemK2m, Inc.201511—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K190751Connector SystemOrthofix, Inc.20193—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—