510(k) Report

Devices descending from K013877

257 later devices reach Codman Slim-Loc System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+4K141632Zevo (TM) Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.2014181
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K140361Meta-C Cervical PlateMedacta International20140—
+4K130640Atlantis Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.201332—
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+4K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+4K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231090Zevo Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20231—
+5K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+5K223753Cervical Plate SystemDouble Medical Technology, Inc.20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc.20193—
+5K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd.20191—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K152623ATLANTIS Anterior Cervical Plate SystemMedtronic Sofamor Danek USA, Inc.20159—
+5K143706FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC20151—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K260570corra™ cervical plating systemCarlsmed, Inc.20261—
+6K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223321Omnia Medical Coupler-C Anterior Cervical PlateOmnia Medical, LLC20230—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K230026SqualeImplanet, S.A.20230—
+7K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+7K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K201287Impulse Interbody Fusion SystemDegen Medical20208—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—