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FDA 510(k) Application Details - K150661
Device Classification Name
Pin, Fixation, Threaded
More FDA Info for this Device
510(K) Number
K150661
Device Name
Pin, Fixation, Threaded
Applicant
CITIEFFE s.r.l
Via Armaroli 21
Calderara di Reno 400012 IT
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Contact
Stefano Pullega
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/13/2015
Decision Date
07/07/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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