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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/Polymer, Porous Uncemented
510(k) Number K252623
Device Name G7® Revision Acetabular System
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact Serena Guiducci
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact Serena Guiducci
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
KWZ   LZO   OQG   OQH   OQI  
PBI  
Date Received08/19/2025
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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