510(k) Report

Devices descending from K080442

14 later devices reach Seriscaffold Surgical Mesh through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123128Seri Surgical ScaffoldAllergan20135—
+1K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K172545SERI ContourSofregen Medical, Inc.20170—
+2K140533Galaflex MeshTepha, Inc.20143—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K202425SurgiLattice scaffoldTepha, Inc.20210—
+3K162922GalaFORM 3DTepha, Inc.20170—
+3K161092GalaSHAPE 3DTepha, Inc.201611
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—