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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
510(k) Number K200122
Device Name MOTO PFJ System
Applicant
Medacta International SA
Strada Regina
Castel San Pietro,  CH CH-6874
Applicant Contact Stefano Baj
Correspondent
Medacta USA
3973 Delp Street
Memphis,  TN  38118
Correspondent Contact Chris Lussier
Regulation Number888.3540
Classification Product Code
KRR  
Subsequent Product Codes
JWH   NPJ  
Date Received01/21/2020
Decision Date 04/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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