510(k) Report

Devices descending from K040261

51 later devices reach Reflex Hybrid Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200883CarboClear® Cervical Plate SystemCarboFix Orthopedics, Ltd.20200—
+1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+1K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159—
+1K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+1K083020Stryker Spine Reflex Translational Anterior Cervical Plating SystemStryker Corp.20093—
+1K083562Stryker Spine Nulock Anterior Cervical Plating SystemStryker Corp.200916—
+1K063430Zero Profile Anterior Cervical Plate (Acp) SystemStryker Spine20072—
+1K062310Reflex Hybrid Acp SystemStryker Spine2006222
+1K043066Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology200527—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K240484MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20240—
+2K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+2K180772Met One Czar Anterior Cervical Plate SystemMet One Technologies20180—
+2K172086Matira™ Anterior Cervical SystemKalitec Direct, LLC20170—
+2K150759Hyper-C Anterior Cervical Plate SystemDegen Medical20154—
+2K150700ACP 1 Anterior Cervical Plating SystemStryker Corporation20150—
+2K100708Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology201012—
+2K083663PACPPioneer Surgical Technology200917—
+2K073500Active Anterior Cervical Plate SystemSanacor20080—
+2K053053Pacp SystemPioneer Surgical Technology200525—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K183060CervAlign™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201921
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC20180—
+3K130427Pioneer Aspect Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20135—
+3K122216Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC20123—
+3K111528Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc.201111—
+3K072703Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology200819—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC20221—
+4K211408CervAlign® Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20211—
+4K133245Genesys Spine Anterior Cervical Plate II SystemGenesys Spine201411
+4K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC20142—
+4K121658Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc.20124—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC20260—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K192076Binary® Anterior Cervical Plate SystemGenesys Spine20190—
+5K130825Azure Anterior Cervical Plate SystemOrthofix, Inc.201311
+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—
+6K143028Azure Anterior Cervical Plate SystemOrthofix, Inc.20150—