FDA 510(k) Application Details - K060131

Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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510(K) Number K060131
Device Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
PO BOX 587
WARSAW, IN 46581-0587 US
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Contact TRACY BICKEL JOHNSON
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Regulation Number 888.3510

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Classification Product Code KRO
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Date Received 01/18/2006
Decision Date 02/15/2006
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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