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FDA 510(k) Application Details - K112905
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
More FDA Info for this Device
510(K) Number
K112905
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant
BIOMET ORTHOPEDICS LLC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact
GARY BAKER
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Regulation Number
888.3670
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Classification Product Code
MBF
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More FDA Info for this Product Code
Date Received
10/03/2011
Decision Date
05/24/2012
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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