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FDA 510(k) Application Details - K031428
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K031428
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact
BONNIE J SMITH
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
LXT
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More FDA Info for this Product Code
Date Received
05/06/2003
Decision Date
08/08/2003
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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