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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone cement, antibiotic
510(k) Number K131135
Device Name BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact Carmen Albany
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact Carmen Albany
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Codes
HSD   KWS  
Date Received04/22/2013
Decision Date 01/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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