INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES

INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES is an FDA 510(k)-cleared medical device (K970705) manufactured by Sulzer 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 May 21, 1997. Regulation: 8.