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Trinity Orthopedics, LLC
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MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K081790) manufactured by Trinity Orthopedics, 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 July 23, 2008. Regulation: 8.