
Spinal Concepts, Inc.
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HARMONY PORT SYSTEM, MODEL 1907 SERIES is an FDA 510(k)-cleared medical device (K050706) manufactured by Spinal Concepts, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2005. Regulation: 8.