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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/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K212746
Device Name ATTUNE Revision Cones
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Erin Combs
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Correspondent Contact Kathy Boggs
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received08/30/2021
Decision Date 10/17/2022
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
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