510(k) Report

Devices descending from K945700

692 later devices reach Synthes (Usa) Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K230026SqualeImplanet, S.A.20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—