HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM is an FDA 510(k)-cleared medical device (K130907) manufactured by Stryker Trauma AG. 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 9, 2013. Regulation: 8.