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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K872454
Device Name BIOMET MODULAR SHOULDER 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 Number888.3650
Classification Product Code
KWT  
Date Received06/23/1987
Decision Date 08/27/1987
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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