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FDA 510(k) Application Details - K092568
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K092568
Device Name
System, Facet Screw Spinal Device
Applicant
AMENDIA, INC.
13540 GUILD AVENUE
APPLE VALLEY, MN 55124 US
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Contact
RICHARD JANSEN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MRW
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More FDA Info for this Product Code
Date Received
08/20/2009
Decision Date
11/17/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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