FDA 510(k) Application Details - K071271

Device Classification Name Cerclage, Fixation

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510(K) Number K071271
Device Name Cerclage, Fixation
Applicant BIOMET MANUFACTURING, INC.
P.O. BOX 587
WARSAW, IN 46581-0578 US
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Contact BECKY EARL
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Regulation Number 888.3010

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Classification Product Code JDQ
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Date Received 05/07/2007
Decision Date 10/23/2007
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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