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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, Constrained, Cemented, Metal/Polymer
510(k) Number K020381
Device Name EXPANDABLE KNEE
Applicant
BIOMET ORTHOPEDICS, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
BIOMET ORTHOPEDICS, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3510
Classification Product Code
KRO  
Date Received02/05/2002
Decision Date 05/06/2002
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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