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FDA 510(k) Application Details - K062920
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
More FDA Info for this Device
510(K) Number
K062920
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant
ORTHOFIX SRL
15058 ARMEL DR.
OREGON CITY, OR 97045 US
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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
09/28/2006
Decision Date
11/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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