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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 K111746
Device Name COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
warsaw,  IN  46581 -0587
Applicant Contact patricia sandborn beres
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
warsaw,  IN  46581 -0587
Correspondent Contact patricia sandborn beres
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
JDC   KWS   MBF  
Date Received06/21/2011
Decision Date 12/15/2011
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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