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510(k) K160700

ATTUNE Revision Knee System by Depuy(Ireland) — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2016
Date Received
March 14, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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  • K140881 — DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (February 13, 2015)
  • K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM (April 3, 2014)

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