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Orthofix M6-C Disc Gains FDA Premarket Approval -

Orthofix Medical (OFIX) received FDA Premarket Approval of the M6-C™ artificial cervical disc. Limited U.S. market launch will occur within 2019. M6-C was developed by Spinal Kinetics, which OFIX acquired in 2018. The device received CE Mark approval in 2006 and has been implanted more than 45,000 times since then, outside of the U.S. The PMA was based on clinical data from a U.S. Investigational Device Exemption study comparing M6-C to anterior cervical discectomy and fusion to treat cervical radiculopathy. The prospective, non-randomized, concurrently controlled, multi-center clinical trial was conducted at 23 sites. (Orthofix Medical Inc., 2/7/19)