Crystal ®; Mosaic ®; Vertu ®

Crystal ®; Mosaic ®; Vertu ® is an FDA 510(k)-cleared medical device (K133218) manufactured by Spinal Elements, 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 December 9, 2014. Regulation: 8.