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FDA 510(k) Application Details - K113384
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K113384
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
CITIEFFE
110 E. GRANADA BLVD.
SUITE 209
ORMOND BEACH, FL 32176 US
Other 510(k) Applications for this Company
Contact
Claude Berthoin
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/16/2011
Decision Date
05/01/2012
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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