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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 K081038
Device Name ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact CHRIS MCKEE
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact CHRIS MCKEE
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/11/2008
Decision Date 08/15/2008
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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