510(k) Report

Devices descending from K972813

6 later devices reach Gamma Locking Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143245GPC Intramedullary Nailing SystemsGpc Medical Limited20152—
+1K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)20042—
+2K253517Reselute Tibial NailReselute, Inc.20260—
+2K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+2K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.20111—
+3K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—