510(k) Report

Devices descending from K071667

26 later devices reach Synthes Vectra-One System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152239Zero-P Natural Plate SystemSynthes (Usa), LLC20150—
+1K143576Exactech AmbassadorExactech, Inc.201571
+1K130030Zavation Cervical Plate SystemZavation, LLC201315—
+1K112748Slimplicity Solo Anterior Cervical Plate SystemSpinal USA, LLC20120—
+2K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+2K200170SpineNet SSP SystemSpinenet, LLC20200—
+2K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP20194—
+2K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+2K173867Axis Anterior Cervical Plate SystemAxis Orthopaedics20181—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+2K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+2K150666uNion Cervical Plate SystemUlrich Medical USA201531
+3K243369Cervical Plating SystemLife Spine, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+3K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+3K203154KASILOF Cervical Plate SystemKahtnu Surgical, Inc.20200—
+3K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+3K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—