Biomet Headless Compression and Twist-Off Screws

Biomet Headless Compression and Twist-Off Screws is an FDA 510(k)-cleared medical device (K190035) 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 February 6, 2019. Regulation: 8.