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Stryker Leibinger
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STRYKER PATIENT SPECIFIC POLYMER IMPLANT is an FDA 510(k)-cleared medical device (K043250) manufactured by Stryker Leibinger. 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 April 14, 2005. Regulation: 8.