FDA 510(k) Application Details - K063570

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K063570
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
PO BOX 587
WARSAW, IN 46581-0587 US
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Contact BECKY EARL
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 11/29/2006
Decision Date 02/27/2007
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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