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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K950717
Device Name AUGMENT-T POSTERIOR SPINAL 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
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received02/16/1995
Decision Date 02/14/1996
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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