
Davol Inc., Subsidiary of C.R. Bard
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OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners is an FDA 510(k)-cleared medical device (K191287) manufactured by Davol Inc., Subsidiary of C.R. Bard. 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 July 15, 2019. Regulation: 8.