STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE

STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE is an FDA 510(k)-cleared medical device (K926384) manufactured by Zimmer, 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 November 15, 1993. Regulation: 8.