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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 + additive, cemented
510(k) Number K121183
Device Name COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
Original Applicant
BIOMET CORPORATION
56 east bell drive
warsaw,  IN  46580
Original Contact patricia sandborn beres
Regulation Number888.3660
Classification Product Code
PAO  
Subsequent Product Code
KWS  
Date Received05/08/2012
Decision Date 07/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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