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FDA 510(k) Application Details - K052043
Device Classification Name
System, Facet Screw Spinal Device
More FDA Info for this Device
510(K) Number
K052043
Device Name
System, Facet Screw Spinal Device
Applicant
TRIAGE MEDICAL, INC.
13700 ALTON PKWY., SUITE 160
IRVINE, CA 92618 US
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Contact
GAYLE HIROTA
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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
07/28/2005
Decision Date
10/17/2005
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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