510(k) Report

Devices descending from K080353

4 later devices reach LTM-T Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091499Medeor Matrix, Models 30010-XX (Hydrated); 30020-XX (Dry)Kensey Nash Corp.20093—
+2K103787Medeor MatrixKensey Nash Corp.20112—
+3K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.20250—
+3K133169Meso Tendon MatrixKensey Nash Corporation Dba Dsm Biomedical20130—