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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K132239
Device Name COMPREHENSIVE REVERSE SHOULDER SCREWS
Applicant
BIOMET MANUFACTURING CORP.
56 BELL DRIVE
WARSAW,  IN  46580
Applicant Contact PATRICIA S BERES
Correspondent
BIOMET MANUFACTURING CORP.
56 BELL DRIVE
WARSAW,  IN  46580
Correspondent Contact PATRICIA S BERES
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   PAO  
Date Received07/18/2013
Decision Date 09/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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