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FDA 510(k) Application Details - K053101
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K053101
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
MEDTRONIC SOFAMOR DANEK
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
NKB
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More FDA Info for this Product Code
Date Received
11/04/2005
Decision Date
01/05/2006
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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