INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY

INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY is an FDA 510(k)-cleared medical device (K121482) manufactured by Theken Spine, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 2012. Regulation: 8.