
Pontis Orthopaedics, LLC
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FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP is an FDA 510(k)-cleared medical device (K140127) manufactured by Pontis Orthopaedics, LLC. 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 May 27, 2014. Regulation: 8.