PWB LUMBOSACRAL SPINE SYSTEM

PWB LUMBOSACRAL SPINE SYSTEM is an FDA 510(k)-cleared medical device (K920116) manufactured by Cross Medical Products, 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 April 9, 1992. Regulation: 8.