Medtronic Sofamor Danek USA, Inc.

Medtronic Sofamor Danek USA, Inc. — FDA 510(k) Submissions

Medtronic Sofamor Danek USA, Inc. has submitted 169 FDA 510(k) premarket notifications since 2000, of which 158 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Orthopedic Stereotaxic Instrument, Appliance, Fixation, Spinal Interlaminal, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.