510(k) Report

Devices descending from K792352

717 later devices reach Synthes Cervical Vertabrae Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+10K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+10K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+10K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+10K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+10K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+10K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+10K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+10K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+10K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K211740DualXAmplify Surgical, Inc.20211—
+10K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+10K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+10K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+10K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+10K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+10K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+10K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+10K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+10K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+10K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+10K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+11K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+11K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+11K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+11K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+11K223418DeGen Impulse AM™ SystemDegen Medical20236—
+11K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+11K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+11K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+11K213417Ghost Spacer SystemLife Spine, Inc.20220—
+11K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+11K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+11K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+11K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+11K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+11K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+11K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+11K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+11K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+12K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+12K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+12K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+12K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+12K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+12K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+12K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+12K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—