OsteoFab Suture Anchors

OsteoFab Suture Anchors is an FDA 510(k)-cleared medical device (K190915) manufactured by Oxford Performance Materials, 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 July 2, 2019. Regulation: 8.