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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 K852585
Device Name POROUS APF/MODULAR FEMORAL COMPONENT
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact JUDITH DERMODY
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact JUDITH DERMODY
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/18/1985
Decision Date 08/22/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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