STRYKER PATIENT SPECIFIC POLYMER IMPLANT

STRYKER PATIENT SPECIFIC POLYMER IMPLANT is an FDA 510(k)-cleared medical device (K103010) manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. 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 October 25, 2010. Regulation: 8.