510(k) Report

Devices descending from K040962

1,130 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240963Spinal SystemTeslake, Inc.20240—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+6K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181397DualXInnovasive, Inc.201815—
+6K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+6K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+6K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+6K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162367Erisma® LP MISClariance, Sas20162—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+6K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+6K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+6K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+6K103292Trio Trauma Spinal SystemStryker Corporation201185—