
International Medical Systems
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MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K990515) manufactured by International Medical Systems. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 1999. Regulation: 8.