510(k) Report

Devices descending from K043488

1,128 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+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—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+4K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K140738Pass LP Spinal SystemMedicrea International201447—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K131833Centurion Poct SystemOrthofix, Inc.20142—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132575Pass LP Spinal SystemMedicrea International20130—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K130176Firebird Spinal Fixation SystemOrthofix20135—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+4K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+4K121728Tiger Spine SystemCorelink, LLC201250—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—