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Stanmore Implants Worldwide , Ltd.
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JTS EXTENDEABLE IMPLANT is an FDA 510(k)-cleared medical device (K092138) manufactured by Stanmore Implants Worldwide , Ltd.. 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 21, 2011. Regulation: 8.