510(k) Report

Devices descending from K222978

4 later devices reach Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+1K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited20250—
+1K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+2K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—