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FDA 510(k) Application Details - K021705
Device Classification Name
System, Facet Screw Spinal Device
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510(K) Number
K021705
Device Name
System, Facet Screw Spinal Device
Applicant
MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD TREHARNE
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Regulation Number
000.0000
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Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
05/23/2002
Decision Date
07/24/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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