ASCENSION PYROSPHERE (PCS)

ASCENSION PYROSPHERE (PCS) is an FDA 510(k)-cleared medical device (K042690) manufactured by Ascension Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 2004. Regulation: 8.