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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 K241059
Device Name Pantheon Proximal Femur Reconstruction (PFR) System
Applicant
Adler Ortho S.P.A
9 Via Dell’Innovazione
Cormano (Mi),  IT 20032
Applicant Contact Davide Cremascoli
Correspondent
MCRA, LLC
803 7th St. NW
Floor 3
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO   MBL  
Date Received04/18/2024
Decision Date 01/13/2025
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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