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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral Component, Cemented, Metal
510(k) Number K212431
Device Name Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
Applicant
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact Gregory Foster
Correspondent
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact Gregory Foster
Regulation Number888.3360
Classification Product Code
JDG  
Subsequent Product Code
LZO  
Date Received08/04/2021
Decision Date 02/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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