December 1997 AAOS Report

Sofamor-Danek receives 510(k) clearance

In other news related to the pedicle screw, the U.S. Food and Drug Administration (FDA) has granted Sofamor-Danek a 510(k) clearance for the use of certain of its bone screws in the pedicle for degenerative disk disease. A 510(k) clearance means that the FDA has determined, based on information provided by the manufacturer, that the device is "substantially equivalent" to one which was in the market before May 1976, when the FDA amendments creating the FDA's device classification system were enacted.


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