2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445

2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 is an FDA 510(k)-cleared medical device (K031981) manufactured by Linvatec Biomaterials, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 24, 2003. Regulation: 8.