510(k) Report

Devices descending from K082236

779 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161627PASS LP Spinal SystemMedicrea International SA20167—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+3K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+3K142360Everest Spinal SystemK2m, Inc.201522—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+3K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+3K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+3K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K122592Instinct Java SystemZimmer Spine201301
+3K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—