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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, Uncemented
510(k) Number K193038
Device Name Comprehensive Shoulder System
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46580
Applicant Contact Patricia Sandborn Beres
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46580
Correspondent Contact Patricia Sandborn Beres
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT  
Date Received10/31/2019
Decision Date 10/28/2020
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
Recalls CDRH Recalls
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