
Iame, Inc.
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UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS is an FDA 510(k)-cleared medical device (K021623) manufactured by Iame, 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 September 9, 2002. Regulation: 8.