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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 K063100
Device Name ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact CHRISTINE SCIFERT
Correspondent
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact CHRISTINE SCIFERT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/10/2006
Decision Date 02/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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