MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)

MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) is an FDA 510(k)-cleared medical device (K972913) manufactured by Pacific Materials and Interfaces. 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 29, 1998. Regulation: 8.