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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K013829
Device Name MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICK W TREHARNE
Correspondent
Medtronic Sofamor Danek, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICK W TREHARNE
Classification Product Code
MRW  
Date Received11/19/2001
Decision Date 12/19/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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