HYDROXYLAPATITE INFINITY(R)

HYDROXYLAPATITE INFINITY(R) is an FDA 510(k)-cleared medical device (K920969) manufactured by Dow Corning Wright. 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 4, 1993. Regulation: 8.