510(k) Report

Devices descending from K934429

538 later devices reach Anterior Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+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
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+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—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+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
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+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—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K123552Instinct Java SystemZimmer Spine201301
+4K122592Instinct Java SystemZimmer Spine201301
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K120047Coral Spinal SystemTheken Spine, LLC201214—
+4K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+4K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+4K113270Instinct Java SystemZimmer Spine201121
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K110321Tiger Spine SystemCorelink, LLC201183—
+4K081331Fixxsure Cross LinkSpineworks, LLC200891—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K062912Scient'x Spinal SystemScient'X200736—
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+4K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+4K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+4K061321Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXAlphatec Spine, Inc.20060—
+4K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+4K040747Aladyn Rigid Spine PlateScient'X20040—
+4K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+4K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+4K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+4K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—