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FDA 510(k) Application Details - K052261
Device Classification Name
Spinal Vertebral Body Replacement Device
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510(K) Number
K052261
Device Name
Spinal Vertebral Body Replacement Device
Applicant
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD TREHARNE
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
MQP
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More FDA Info for this Product Code
Date Received
08/19/2005
Decision Date
10/07/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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