510(k) Report

Devices descending from K926453

759 later devices reach Synthes (U.S.a.) Anterior Cervical Vertebrae Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K261049Scala® TLSpineart SA20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—