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FDA 510(k) Application Details - K113011
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K113011
Device Name
System, Facet Screw Spinal Device
Applicant
AMENDIA, INC.
13540 GUILD AVENUE
APPLE VALLEY, MN 55124 US
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Contact
RICH JANSEN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/11/2011
Decision Date
12/06/2011
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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