
Smith & Nephew, Inc.
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ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS is an FDA 510(k)-cleared medical device (K072322) manufactured by Smith & Nephew, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 2007. Regulation: 8.