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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K193540
Device Name TRUMATCH Personalized Solutions
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
WARSAW,  IN  46582
Applicant Contact Erin Combs
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Melissa Cook
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received12/20/2019
Decision Date 06/16/2020
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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