Orthofix International N.V. won CE Mark approval from the European Union for its Advent cervical disc.
The McKinney, Texas-based company, which has operations in Boston, said it plans to begin marketing the device in Europe during the fourth quarter.
It’s also running a study of the Advent disc, involving 100 patients in 15 medical centers, ahead of seeking similar approval from the U.S. Food & Drug Administration. Orthofix plans to add 10 more study sites in the U.S. this year, taking the total number of enrolled patients to 450.