
Rti Surgical, Inc.
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Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is an FDA 510(k)-cleared medical device (K230036) manufactured by Rti Surgical, Inc.. 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 June 22, 2023. Regulation: 8.