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FDA 510(k) Application Details - K082236
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K082236
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132-3576 US
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Contact
BRAD SHEALS
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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
08/07/2008
Decision Date
10/10/2008
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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