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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 K193057
Device Name ATTUNE All-Polyethylene Tibia
Applicant
DePuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Kathy Harris Brocato
Correspondent
DePuy Synthes, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Kellie Myers
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/01/2019
Decision Date 01/30/2020
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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