510(k) Report

Devices descending from K050813

145 later devices reach Abc 2 Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201587icotec Anterior Cervical Plate SystemIcotec AG20201—
+1K133475Struxxure Anterior Cervical Plate and ScrewsNexxt Spine, LLC2013132—
+1K100243Quintex Cervical Plating SystemAesculap Implant Systems, LLC2010101
+2K233215icotec Anterior Cervical Plate SystemIcotec AG20240—
+2K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine20244—
+2K201979Cervical Plate SystemEminent Spine, LLC20201—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K141993Nakoma AcpAlliance Partners, LLC201481
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K121801Quintex Cervical Plating SystemAesculap Implant Systems, LLC20120—
+3K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC20200—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K262149corra® cervical plating systemCarlsmed, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+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—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—