510(k) Report

Devices descending from K132968

12 later devices reach Univise Spinous Process Fixation Plate (35MM, 40MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+1K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+2K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+2K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+2K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+2K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+2K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+3K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+3K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+3K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+4K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+5K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—