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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 K223631
Device Name Comprehensive Segmental Revision System(SRS)
Applicant
Biomet Orthopedics
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact Alexandria Irwin
Correspondent
Biomet Orthopedics
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Alexandria Irwin
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
JDC   KWS   MBF   PHX  
Date Received12/05/2022
Decision Date 07/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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