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FDA 510(k) Application Details - K040167
Device Classification Name
Spinal Vertebral Body Replacement Device
More FDA Info for this Device
510(K) Number
K040167
Device Name
Spinal Vertebral Body Replacement Device
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD TREHARNE
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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
01/26/2004
Decision Date
02/18/2004
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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