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
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+7K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K201671A-Link ZAcuity Surgical Devices, LLC202125—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+7K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811