
Solana Surgical, LLC
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GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET is an FDA 510(k)-cleared medical device (K122738) manufactured by Solana Surgical, 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 November 6, 2012. Regulation: 8.