STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT is an FDA 510(k)-cleared medical device (K111065) manufactured by Howmedica Osteonics Corp. Dba Stryker Orthopeadics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2011. Regulation: 8.