Tag: class III
Paradigm Spine receives FDA pre-market approval (PMA) for first of its...
The US Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for the coflex interlaminar stabilisation disposable instrument kit (Paradigm Spine). This...
US FDA downgrades class III pedicle screws to class II
The US Food and Drug Administration (FDA) has formally reclassified pedicle screws from class III to class II devices. The reclassification came into force...