TekBrace Solo Soft Tissue Reinforcement Device

TekBrace Solo Soft Tissue Reinforcement Device is an FDA 510(k)-cleared medical device (K251063) manufactured by Theramicro. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 29, 2025. Regulation: 8.