
Magly Orthopedics, LLC
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MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM is an FDA 510(k)-cleared medical device (K021579) manufactured by Magly Orthopedics, 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 August 8, 2002. Regulation: 8.