Cleared Special

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

K013829 · Medtronic Sofamor Danek, Inc. · Orthopedic device

Dec 2001

Decision

30d

Days

—

Risk

K013829 is an FDA 510(k) clearance for the MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on December 19, 2001, 30 days after receiving the submission on November 19, 2001.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K013829 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 19, 2001
Decision Date	December 19, 2001
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF