510(k) Report

Devices descending from K992739

912 later devices reach Click'x through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+3K111457CD Horizon Spinal SystemMedtronic Sofamor Danek2011261—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110348Universal Clamp Spinal Fixation SystemZimmer Spine201144—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc.2011269—
+3K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+3K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.2010261
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100788Cocr RodsGlobus Medical, Inc.2010374—
+3K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+3K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+3K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+3K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+3K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+3K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+3K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+3K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+3K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240350AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.20240—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+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—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—