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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K951164
Device Name CD LIBERTY POSTERIOR SPINCAL SYSTEM
Applicant
Sofamor Danek USA,Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek USA,Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received03/14/1995
Decision Date 02/09/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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