510(k) Report

Devices descending from K991031

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+5K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K201648Sterispine™ PSSafe Orthopaedics202011
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—