K013829 - MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM (FDA 510(k) Clearance)

K013829 is an FDA 510(k) clearance for the MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek, Inc. devices