510(k) Report

Devices descending from K112533

26 later devices reach Zavation Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181244Zavation Cervical Plate SystemZavation Medical Products, LLC20187—
+1K180537Zavation Buttress Plate SystemZavation Medical Products, LLC20180—
+1K173306EZ PlateZavation Medical Products, LLC20180—
+1K150666uNion Cervical Plate SystemUlrich Medical USA201531
+1K130030Zavation Cervical Plate SystemZavation, LLC201315—
+2K240515uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.20240—
+2K221053Magnes-C Anterior Cervical Plate SystemFellowship of Orthopaedic Researchers, Inc.20230—
+2K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+2K202227Artus™ cervical plate systemUlrich GmbH & Co. KG20200—
+2K200927Transept Cervical Plate SystemNeurostructures, Inc.20200—
+2K200170SpineNet SSP SystemSpinenet, LLC20200—
+2K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate…Curiteva, LLC20180—
+2K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+2K152455Amendia Cervical Plate SystemAmendia, Inc.20151—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K231593Sapphire X3 Anterior Cervical Plate SystemSpinal Elements, Inc.20230—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K250769Dakota LP SystemPrecision Spine, Inc.20250—
+4K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+5K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—