
Synthes Spine Co.Lp
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ARCOFIX is an FDA 510(k)-cleared medical device (K080020) manufactured by Synthes Spine Co.Lp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 2008. Regulation: 8.