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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, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K032895
Device Name BI-ANGULAR SHOULDER SYSTEM
Applicant
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA S BERES
Regulation Number888.3670
Classification Product Code
MBF  
Date Received09/17/2003
Decision Date 11/20/2003
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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