510(k) Report

Devices descending from K940631

559 later devices reach Cross Medical - Synergy (TM) Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K150185Mont Blanc Spinal SystemSpineway20154—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111301Instinct Java SystemZimmer Spine201131
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+3K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+3K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+3K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K061342Malibu Spinal SystemSeaspine, Inc.2006801
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051942Malibu Spinal SystemSeaspine, Inc.20058111
+3K051663Malibu Spinal SystemSeaspine, Inc.200581—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K043232Ucr Spinal SystemSeaspine2004971
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K032739Ucr Spinal SystemSeaspine2003174—
+3K021623Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc.2002175—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+3K9942885.0MM Spinal ScrewsOrtho Tec, LLC20000—
+3K993926Omniaxial ConnectorOrtho Tec, LLC19990—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+4K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—