
Smith & Nephew, Inc.
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SMITH & NEPHEW MODULAR FEMORAL HEAD is an FDA 510(k)-cleared medical device (K061243) manufactured by Smith & Nephew, 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 July 16, 2006. Regulation: 8.