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510(k) K191779

Attune Revision LPS Inserts by Depuy(Ireland) — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2019
Date Received
July 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Depuy(Ireland)

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  • K190344 — DePuy Corail AMT Hip Prosthesis (November 1, 2019)
  • K192448 — Delta Xtend Revers Shoulder System (October 4, 2019)
  • K183077 — Delta Xtend Reverse Shoulder System (May 17, 2019)
  • K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing (June 15, 2017)
  • K160907 — DePuy Actis DuoFix Hip Prosthesis (July 19, 2016)
  • K160700 — ATTUNE Revision Knee System (June 10, 2016)
  • 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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