510(k) Report

Devices descending from K063712

10 later devices reach Avaulta Support System/Avaulta Plus Biosynthetic Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090288Orthadapt PRPegasus Biologics, Inc.20097—
+1K083839Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support SystemC.R. Bard, Inc.20090—
+1K082571Avaulta Support SystemC.R. Bard, Inc.20081—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+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—