510(k) Report

Devices descending from K001046

9 later devices reach Biopro Glenoid Component W/ Keel & W/ Posts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092474Pyrenees Cervical Plate System, Semi-Constrained ScrewsK2m, Inc.20108—
+2K152281Pyrenees Cervical Plate SystemK2m20156—
+2K142212Pyrenees Cervical Plate SystemK2m, Inc.20150—
+3K172104Ozark (tm) Cervical Plate SystemK2m, Inc.20175—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—