
Ossacur AG
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OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 is an FDA 510(k)-cleared medical device (K042305) manufactured by Ossacur 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 October 20, 2004. Regulation: 8.