510(k) Report

Devices descending from K062310

22 later devices reach Reflex Hybrid Acp System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+1K170342Ocata Anterior Cervical SystemKalitec Direct, LLC20171—
+1K142237Aviator Anterior Cervical Plate (ACP) SystemStryker Corporation20159—
+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—
+2K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC20240—
+2K240484MSFX Mikron Cervical Anterior Plate SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20240—
+2K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+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—
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical20220—
+3K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc.20191—
+3K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+3K181562Curiteva Anterior Cervical Plate SystemCuriteva, LLC20180—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—