• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K160700
Device Name ATTUNE Revision Knee System
Depuy (Ireland)
Loughbeg Ringaskiddy
Co. Cork Munster,  IE
Applicant Contact Jaime Weeks
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw,  IN  46582
Correspondent Contact Soraya L. Hori
Regulation Number888.3560
Classification Product Code
Subsequent Product Code
Date Received03/14/2016
Decision Date 06/10/2016
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