SELECT(R) SHOULDER ALL-POLY GLENOID

SELECT(R) SHOULDER ALL-POLY GLENOID is an FDA 510(k)-cleared medical device (K931114) manufactured by Intermedics Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 8, 1994. Regulation: 8.