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.

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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