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FDA 510(k) Application Details - K961633
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K961633
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
SOFAMOR DANEK USA,INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD W TREHARNE, PH.D.
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Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
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More FDA Info for this Product Code
Date Received
04/29/1996
Decision Date
12/05/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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