2-Piece Hammertoe Correction System

2-Piece Hammertoe Correction System is an FDA 510(k)-cleared medical device (K162685) manufactured by Life Spine, 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 June 8, 2017. Regulation: 8.