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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
510(k) Number K010212
Device Name OFFSET TIBIAL TRAY
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact CAROL LAUSTER
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact CAROL LAUSTER
Regulation Number888.3560
Classification Product Code
MBV  
Date Received01/23/2001
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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