510(k) Report

Devices descending from K991031

878 later devices reach Colorado II Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172469TiLock Modular Spinal SystemGenesys Spine20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+4K161627PASS LP Spinal SystemMedicrea International SA20167—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+4K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+4K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+4K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133287Presson Spinal Fixation SystemNexus Spine, LLC20141—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+4K131533Cayman MI Plate SystemK2m, Inc.201372—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122592Instinct Java SystemZimmer Spine201301
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+4K111479Revere CrosstopGlobus Medical, Inc.2011232—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K080767Conquest Spinal SystemLife Spine200821—
+5K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+5K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—