BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE is an FDA 510(k)-cleared medical device (K925098) manufactured by Bioscience, 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 July 18, 1994. Regulation: 8.