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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K022094
Device Name PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
Applicant
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact TRACY J BICKEL
Correspondent
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact TRACY J BICKEL
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received06/27/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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