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Zimmer, Inc.
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ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES is an FDA 510(k)-cleared medical device (K082078) manufactured by Zimmer, 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 November 2, 2008. Regulation: 8.