
The Skeletal Design Partnership , Ltd.
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FOUNDATION SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K120074) manufactured by The Skeletal Design Partnership , 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 13, 2012. Regulation: 8.