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Smith & Nephew, Inc.
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SMITH & NEPHEW R3 CONSTRAINED LINERS is an FDA 510(k)-cleared medical device (K122139) 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 October 15, 2012. Regulation: 8.