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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, Hemi-, Femoral, Metal
510(k) Number K845025
Device Name AUSTIN-MOORE MODULAR HIP PROSTHESIS
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 Number888.3360
Classification Product Code
KWL  
Date Received12/27/1984
Decision Date 04/19/1985
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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