THEKEN ATOLL OCT SPINAL SYSTEM

THEKEN ATOLL OCT SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K083863) 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 March 26, 2009. Regulation: 8.