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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 + additive/metal/polymer + additive
510(k) Number K201347
Device Name DePuy ATTUNE™ Total Knee System
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
warsaw,  IN  46582
Applicant Contact karen mahoney
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
warsaw,  IN  46582
Correspondent Contact mary wood
Regulation Number888.3560
Classification Product Code
OIY  
Subsequent Product Codes
JWH   MBH  
Date Received05/21/2020
Decision Date 06/18/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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