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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 K214001
Device Name Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
Applicant
Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw,  IN  46582
Applicant Contact Aishwarya Pandey
Correspondent
Biomet Manufacturing Corp.
56 East Bell Drive
Warsaw,  IN  46582
Correspondent Contact Aishwarya Pandey
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   KWT   MBF   PAO  
Date Received12/21/2021
Decision Date 03/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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