510(k) Report

Devices descending from K971883

531 later devices reach Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K233684TriALTIS™ Spine SystemMedos International SARL20234—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230026SqualeImplanet, S.A.20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—