Icotec AG

Icotec AG — FDA 510(k) Submissions

Icotec AG has submitted 16 FDA 510(k) premarket notifications since 2016, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Bone Cement, Posterior Screw Augmentation, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Bone Graft, Cervical, Spinal Vertebral Body Replacement Device . Use the specialty filter in the sidebar to narrow results.