510(k) Report

Devices descending from K926453

759 later devices reach Synthes (U.S.a.) Anterior Cervical Vertebrae Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+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—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+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—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+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—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+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—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+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—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—