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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 K060692
Device Name COMPREHENSIVE PRIMARY SHOULDER STEMS
Applicant
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUSAN ALEXANDER
Correspondent
BIOMET MANUFACTURING CORP.
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT  
Date Received03/15/2006
Decision Date 05/30/2006
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
Recalls CDRH Recalls
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