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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K153398
Device Name Comprehensive SRS/Nexel Elbow
Applicant
Biomet Manufacturing Corp
56 Bell Dr.
Warsaw,  IN  46580
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet Manufacturing Corp
56 Bell Dr.
Warsaw,  IN  46580
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3150
Classification Product Code
JDC  
Subsequent Product Codes
KWS   KWT   MBF  
Date Received11/24/2015
Decision Date 02/03/2016
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
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