SUTTER PHALANGEAL CAP

SUTTER PHALANGEAL CAP is an FDA 510(k)-cleared medical device (K875249) manufactured by Sutter Biomedical, 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 February 2, 1988. Regulation: 8.