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FDA 510(k) Applications Submitted by DEPUY (IRELAND)
FDA 510(k) Number
Submission Date
Device Name
Applicant
K192855
10/04/2019
DELTA XTEND(TM) Reverse Shoulder System
DePuy (Ireland)
K170806
03/17/2017
ATTUNE Cemented Tibial Base, Fixed Bearing
DePuy (Ireland)
K160700
03/14/2016
ATTUNE Revision Knee System
Depuy (Ireland)
K160907
04/01/2016
DePuy Actis DuoFix Hip Prosthesis
DEPUY (IRELAND)
K190344
02/14/2019
DePuy Corail AMT Hip Prosthesis
DePuy (Ireland)
K191779
07/02/2019
Attune Revision LPS Inserts
Depuy (Ireland)
K212683
08/24/2021
GLOBAL ICON Stemless Shoulder System
DePuy (Ireland)
K133834
12/17/2013
DEPUY GLOBAL UNITE SHOULDER SYSTEM
DEPUY (IRELAND)
K140881
04/07/2014
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
DEPUY (IRELAND)
K101996
07/15/2010
DEPUY GLOBAL UNITE SHOULDER SYSTEM
DEPUY (IRELAND)
K102080
07/26/2010
DEPUY RECLAIM REVISION HIP SYSTEM
DEPUY (IRELAND)
K183077
11/05/2018
Delta Xtend Reverse Shoulder System
DePuy (Ireland)
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