510(k) Report

Devices descending from K052292

137 later devices reach Spider Cervical Plating (SCP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+1K171797TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart20180—
+1K170224Spider Cervical Plating SystemX-Spine Systems, Inc.20171—
+1K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart201617
+1K150834Atrax Anterior Cervical Plating SystemX-Spine Systems, Inc.20150—
+1K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+1K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+1K103505Altum Anterior Cervical PlateSpinecraft, LLC201111
+1K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+1K090861Mambo, Model CS 18XX-XXUlrich GmbH & Co. KG20100—
+1K093776Indus Anterior Cervical Plate SystemSpinefrontier, Inc.201016—
+1K080690Manta Ray Anterior Cervical Plate SystemTheken Spine, LLC200802
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+2K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+2K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+2K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+2K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20160—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+2K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+2K131521Velox Anterior Cervical Plate SystemSpinecraft, LLC20130—
+2K131512Katia SystemShanghai Sanyou Medical Co, Ltd.20131—
+2K121060Spine Frontier Indus Acp SystemSpinefrontier, Inc.2012156
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221578Hexanium ACIFSpinevision, S.A.S.20224—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+3K153526Pyrenees Cervical Plate SystemK2m20166—
+3K140234Aspiron Acp SystemU&I Corp.20146—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K190053SECULOK™ ACP SystemU&I Corporation20191—
+4K182055SECULOK™ ACP SystemU&I Corporation20182—
+4K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230026SqualeImplanet, S.A.20230—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K220147Aspiron S ACP SystemU&I Corporation20220—
+5K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371