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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K121982
Device Name SOVEREIGN SPINAL SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Applicant Contact LAUREN KAMER
Correspondent
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS,  TN  38132
Correspondent Contact LAUREN KAMER
Regulation Number888.3080
Classification Product Code
OVD  
Date Received07/06/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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