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Quantum Orthopedics, Inc.
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MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT is an FDA 510(k)-cleared medical device (K062004) manufactured by Quantum Orthopedics, 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 August 14, 2006. Regulation: 8.