REVERTO 55 AND 37 SHAPE MEMORY STAPLES

REVERTO 55 AND 37 SHAPE MEMORY STAPLES is an FDA 510(k)-cleared medical device (K071477) manufactured by Core Essence Orthopaedics, LLC. 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 14, 2007. Regulation: 8.