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FDA 510(k) Application Details - K050631
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device
510(K) Number
K050631
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact
SHERI L MUSGNUNG
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
LXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/11/2005
Decision Date
04/11/2005
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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