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FDA 510(k) Application Details - K072161
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K072161
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW, IN 46581-0587 US
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Contact
BECKY EARL
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
08/06/2007
Decision Date
09/20/2007
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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