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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 K953076
Device Name TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
Applicant
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek USA,Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Classification Product Code
MRW  
Date Received06/30/1995
Decision Date 02/28/1997
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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