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FDA 510(k) Application Details - K102843
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K102843
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
BIOMET TRAUMA (AKA EBI LLC)
100 INTERPACE PARKWAY
PARISPPANY, NJ 07054 US
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Contact
MARGARET F CROWE
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2010
Decision Date
05/03/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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