INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)

INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) is an FDA 510(k)-cleared medical device (K972393) 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 September 18, 1997. Regulation: 8.