
Mikron Makina Sanayi VE Ticaret Ltd. Sti.
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MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS is an FDA 510(k)-cleared medical device (K130073) manufactured by Mikron Makina Sanayi VE Ticaret Ltd. Sti.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2013. Regulation: 8.