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
+4K201648Sterispine™ PSSafe Orthopaedics202011
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+4K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+4K183381Navigation Enabled InstrumentsStryker20191—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173508Everest Spinal SystemK2m20189—
+4K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+4K171321K2M Navigation InstrumentsK2m201711
+4K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+4K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—