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FDA 510(k) Application Details - K022423
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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510(K) Number
K022423
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
RIGID FX ORTHOPEDICS, INCORPORATED
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
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J.D. WEBB
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Regulation Number
888.3030
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Classification Product Code
KTT
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More FDA Info for this Product Code
Date Received
07/24/2002
Decision Date
09/17/2002
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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