ACUMED SMALL BONE LOCKING ROD SYSTEM II

ACUMED SMALL BONE LOCKING ROD SYSTEM II is an FDA 510(k)-cleared medical device (K031438) manufactured by Acumed, 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 July 16, 2003. Regulation: 8.