IMSE P-TLIF

IMSE P-TLIF is an FDA 510(k)-cleared medical device (K130506) manufactured by Institute of Musculoskeletal Science & Education. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2013. Regulation: 8.