510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K230026SqualeImplanet, S.A.20230—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—