MASS (MICRO-ACCESS SPINE SYSTEM)

MASS (MICRO-ACCESS SPINE SYSTEM) is an FDA 510(k)-cleared medical device (K992583) manufactured by Omni-Tract Surgical, Div. Minn. Scientific, 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 28, 1999. Regulation: 8.