Ascension Silicone MCP; Ascension Silicone PIP

Ascension Silicone MCP; Ascension Silicone PIP is an FDA 510(k)-cleared medical device (K233670) manufactured by Ascension Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 2023. Regulation: 8.