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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 K000254
Device Name PAR 5 ACETABULAR COMPONENT
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/28/2000
Decision Date 02/07/2000
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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