
Theken Surgical,Llc
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THEKEN REVEAL VBR SYSTEM is an FDA 510(k)-cleared medical device (K050058) manufactured by Theken 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 May 16, 2005. Regulation: 8.