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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K250834
Device Name Zimmer Biomet Ceramic Heads (22.2mm diameter)
Applicant
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Sean Gleason
Correspondent
Zimmer Biomet
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Sean Gleason
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   KWZ  
Date Received03/19/2025
Decision Date 04/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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