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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K242871
Device Name ATTUNE™ Revision Hinge Knee
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Paige Myers
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Paige Myers
Regulation Number888.3510
Classification Product Code
KRO  
Date Received09/23/2024
Decision Date 11/21/2024
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
Recalls CDRH Recalls
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