
Smith and Nephew, Inc.
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Regeneten Bioinductive Implant is an FDA 510(k)-cleared medical device (K222501) manufactured by Smith and Nephew, 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 May 10, 2023. Regulation: 8.