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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Trade NameBIAS(R) FIBER METAL TOTAL HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Generic Nametotal hip system
Regulation Number888.3358
ApplicantZIMMER, INC.
PMA NumberP850061
Supplement NumberS001
Date Received02/08/1989
Decision Date03/29/1989
Product Code
LPH[ Registered Establishments with LPH ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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