SPINE SYSTEM SACRAL PLATE

SPINE SYSTEM SACRAL PLATE is an FDA 510(k)-cleared medical device (K953881) manufactured by J.B.S., S.A.. 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 20, 1996. Regulation: 8.