
Omni Surgical, L.P.
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BLACK WIDOW ANTERIOR BUTTRESS PLATE is an FDA 510(k)-cleared medical device (K081770) manufactured by Omni Surgical, L.P.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2009. Regulation: 8.