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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 K191779
Device Name Attune Revision LPS Inserts
Applicant
Depuy(Ireland)
Loughbeg Ringaskiddy
Cork,  IE
Applicant Contact Kathy Harris
Correspondent
Depuy Orthopaedies, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Soraya L. Hori
Regulation Number888.3510
Classification Product Code
KRO  
Date Received07/02/2019
Decision Date 10/08/2019
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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