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FDA 510(k) Application Details - K020311
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K020311
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
RIGID FX ORTHOPEDICS, INCORPORATED
3601 S. CONGRESS, BLDG B #300
AUSTIN, TX 78704 US
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MARK ESTRADA
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Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
01/29/2002
Decision Date
04/29/2002
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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