STRYKER INJECTABLE CEMENT

STRYKER INJECTABLE CEMENT is an FDA 510(k)-cleared medical device (K051603) manufactured by Stryker Leibinger Micro Implants. 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 29, 2005. Regulation: 8.