510(k) Report

Devices descending from K011508

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K141044M.U.S.T. ExtensionMedacta International201416—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132878M.U.S.T. ExtensionMedacta International201328—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+6K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253249TriALTIS™ Spine SystemMedos International SARL20251—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252437JAZZ Spinal SystemImplanet20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—