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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K161592
Device Name Persona Partial Knee System
Applicant
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581
Applicant Contact Nicole J. Meredith
Correspondent
BIOMET, INC.
56 EAST BELL DR.
PO Box 587
WARSAW,  IN  46581
Correspondent Contact Nicole J. Meredith
Regulation Number888.3520
Classification Product Code
HSX  
Date Received06/09/2016
Decision Date 11/03/2016
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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