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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 K251043
Device Name Mpact 3D Metal Implants Extension – DMLS Technology
Applicant
Medacta International S.A.
Strada Regina
San Pietro,  CH 6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
6386 Global Dr.
Suite 101
Memphis,  TN  38141
Correspondent Contact Christopher Lussier
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received04/03/2025
Decision Date 01/28/2026
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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