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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 K021559
Device Name ASCENT ALL-POLY PS TIBIAL BEARINGS
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact DALENE T BINKLEY
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/13/2002
Decision Date 06/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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