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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
Depuy (Ireland)
Loughbeg Ringaskiddy
Co. Cork Munster,  IE
Applicant Contact Kathy Harris
Depuy Orthopaedies, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Soraya L. Hori
Regulation Number888.3510
Classification Product Code
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
Recalls CDRH Recalls