STATAK SOFT TISSUE ATTACHMENT DEVICE

STATAK SOFT TISSUE ATTACHMENT DEVICE is an FDA 510(k)-cleared medical device (K962397) 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 August 26, 1996. Regulation: 8.