TENTATIVELY POLARUS EX ROD

TENTATIVELY POLARUS EX ROD is an FDA 510(k)-cleared medical device (K952534) manufactured by Acu-Med, 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 July 12, 1995. Regulation: 8.