GSO GS1 SPACER

GSO GS1 SPACER is an FDA 510(k)-cleared medical device (K071274) manufactured by Gold Standard Orthopedics, 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 23, 2007. Regulation: 8.