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FDA 510(k) Application Details - K040072
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K040072
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD TREHARNE
Other 510(k) Applications for this Contact
Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
01/14/2004
Decision Date
02/12/2004
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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