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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 K844941
Device Name CFE ACETABULAR CUP
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact LONNIE WITHAM
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact LONNIE WITHAM
Regulation Number888.3350
Classification Product Code
JDI  
Date Received12/20/1984
Decision Date 03/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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