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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/Metal/Polymer
510(k) Number K170806
Device Name ATTUNE Cemented Tibial Base, Fixed Bearing
Applicant
DePuy (Ireland)
Loughbeg Ringaskiddy
Co. Cork Munster,  IE
Applicant Contact Carol S. Ming
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Nancy Friddle
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received03/17/2017
Decision Date 06/15/2017
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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