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FDA 510(k) Application Details - K091365
Device Classification Name
Appliance, Fixation, Spinal Interlaminal
More FDA Info for this Device
510(K) Number
K091365
Device Name
Appliance, Fixation, Spinal Interlaminal
Applicant
MEDTRONIC SOAFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
Other 510(k) Applications for this Company
Contact
MELISA LANSKY
Other 510(k) Applications for this Contact
Regulation Number
888.3050
More FDA Info for this Regulation Number
Classification Product Code
KWP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/08/2009
Decision Date
08/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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