510(k) Report

Devices descending from DEN110002

22 later devices reach System 1E Process Biological Monitoring Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180553VERIFY Spore Test Strip for S40 SterilantSTERIS Corporation20182—
+1K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+2K231746VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation20231—
+2K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+2K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+2K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+3K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation20230—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+3K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+4K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+4K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+5K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+6K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+7K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—