510(k) Report

Devices descending from K991031

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K173508Everest Spinal SystemK2m20189—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+5K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K142381Xia 3 Spinal SystemStryker Corp.201483—
+5K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K141044M.U.S.T. ExtensionMedacta International201416—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K130330Range Spinal SystemK2m, Inc.201336—