510(k) Report

Devices descending from K990745

916 later devices reach Modification to Synthes Universal Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+6K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+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—
+6K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+6K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+6K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190016Lateral Plate SystemCorelink, LLC201915—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+6K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—