510(k) Report

Devices descending from K973836

529 later devices reach Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+3K080767Conquest Spinal SystemLife Spine200821—
+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—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+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—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+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—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K123552Instinct Java SystemZimmer Spine201301
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K122592Instinct Java SystemZimmer Spine201301
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K120047Coral Spinal SystemTheken Spine, LLC201214—
+4K113270Instinct Java SystemZimmer Spine201121
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K090320Conquest Spinal SystemLife Spine20092—
+4K081331Fixxsure Cross LinkSpineworks, LLC200891—