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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K142933
Device Name Biomet Tibial trays
Applicant
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact JASON HECKAMAN
Correspondent
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact JASON HECKAMAN
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   MBV  
Date Received10/09/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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