FDA Panel Recommends Class II Designation for Posterior Cervical Screw Fixation

Katherine Sale

In September 2012, the U.S. Food and Drug Administration (FDA) convened a meeting of the Orthopaedic and Rehabilitation Devices Panel to consider whether a Class II device designation would be appropriate for posterior cervical screw fixation (including cervical pedicle and lateral mass screws).

These devices are components of rigid, posterior, spinal screw-and-rod systems generally intended as an adjunct to fusion for the treatment of degenerative disk disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

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