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FDA 510(k) Application Details - K122541
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
More FDA Info for this Device
510(K) Number
K122541
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant
ORTHOFIX SRL
22423 SKYVIEW DRIVE
WEST LINN, OR 97068 US
Other 510(k) Applications for this Company
Contact
CANDACE F CEDERMAN
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/21/2012
Decision Date
09/20/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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