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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 Intervertebral Body
510(k) Number K982875
Device Name MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
Applicant
Danek Medical, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Applicant Contact RICHARD W TREHARNE
Correspondent
Danek Medical, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/14/1998
Decision Date 01/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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