SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM

SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM is an FDA 510(k)-cleared medical device (K940913) manufactured by Spine-Tech, 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 3, 1994. Regulation: 8.