
Gold Standard Orthopaedics, LLC
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GSO GS1 SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K070966) manufactured by Gold Standard Orthopaedics, 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 July 19, 2007. Regulation: 8.