Compress and Mini Compress Anti-Rotation Spindles

Compress and Mini Compress Anti-Rotation Spindles is an FDA 510(k)-cleared medical device (K183553) manufactured by Biomet, 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 January 21, 2019. Regulation: 8.