510(k) Report

Devices descending from K994239

165 later devices reach Zephir Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212139Admiral ACP SystemSeaSpine Orthopedics Corporation20216—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K202878Prase-AP Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20211—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+4K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+4K192494NexGen Anterior Cervical Plate SystemPrecision Spine20190—
+4K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+4K183084Fuji Cervical Plate SystemAltus Partners, LLC20190—
+4K183409Athena II Cervical Plate SystemMedyssey USA, Inc.20191—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K180022Athena Cervical Plate SystemMedyssey USA, Inc.20182—
+4K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC20170—
+4K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+4K162664Pyrenees Cervical Plate SystemK2m, Inc.20165—
+4K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—
+4K132310ASCOTBackroads Consulting, Inc.20130—
+4K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+4K062110Vertebron SCP Cervical Plate SystemVertebron, Inc.20069—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252611aprevo® cervical plating systemCarlsmed, Inc.20253—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+5K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+5K230301Athena III Cervical Plate SystemMedyssey USA, Inc.20230—
+5K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+5K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+5K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+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—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+7K262149corra® cervical plating systemCarlsmed, Inc.20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—