
Innovative Spinal Technologies, Inc.
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PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K072120) manufactured by Innovative Spinal Technologies, 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 October 10, 2007. Regulation: 8.