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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K982398
Device Name BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact FRED MCCLURE
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact FRED MCCLURE
Regulation Number888.3150
Classification Product Code
JDC  
Date Received07/10/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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