
Zimmer Surgical, Inc.
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TotalShield II Surgical Helmet System is an FDA 510(k)-cleared medical device (K192194) manufactured by Zimmer Surgical, 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 October 14, 2019. Regulation: 8.