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U.S. Implant Solutions, LLC
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UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM is an FDA 510(k)-cleared medical device (K081813) manufactured by U.S. Implant Solutions, 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 March 11, 2009. Regulation: 8.