ROTATION MEDICAL BONE STAPLE (RMB STAPLE)

ROTATION MEDICAL BONE STAPLE (RMB STAPLE) is an FDA 510(k)-cleared medical device (K131635) manufactured by Rotation Medical, 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 28, 2013. Regulation: 8.