CERAMIC BALL HEADS, 28, 32 AND 36 MM

CERAMIC BALL HEADS, 28, 32 AND 36 MM is an FDA 510(k)-cleared medical device (K070928) manufactured by Plus Orthopedics AG. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 31, 2007. Regulation: 8.