Medical Device Manufacturer · IE , Cork

Depuy(Ireland) - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2010
13
Total
13
Cleared
0
Denied

Depuy(Ireland) has 13 FDA 510(k) cleared orthopedic devices. Based in Cork, IE.

Last cleared in 2022. Active since 2010.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by DePuy Orthopaedics, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Depuy(Ireland)

13 devices
1-12 of 13
Cleared CT Jan 19, 2022
GLOBAL ICON Stemless Shoulder System
K212683 · PKC
Orthopedic · 148d
Cleared Feb 24, 2020
DELTA XTEND(TM) Reverse Shoulder System
K192855 · PHX
Orthopedic · 143d
Cleared Nov 01, 2019
DePuy Corail AMT Hip Prosthesis
K190344 · LZO
Orthopedic · 260d
Cleared Oct 08, 2019
Attune Revision LPS Inserts
K191779 · KRO
Orthopedic · 98d
Cleared Oct 04, 2019
Delta Xtend Revers Shoulder System
K192448 · PHX
Orthopedic · 28d
Cleared May 17, 2019
Delta Xtend Reverse Shoulder System
K183077 · PHX
Orthopedic · 193d
Cleared Jun 15, 2017
ATTUNE Cemented Tibial Base, Fixed Bearing
K170806 · JWH
Orthopedic · 90d
Cleared Jul 19, 2016
DePuy Actis DuoFix Hip Prosthesis
K160907 · MEH
Orthopedic · 109d
Cleared Jun 10, 2016
ATTUNE Revision Knee System
K160700 · JWH
Orthopedic · 88d
Cleared Feb 13, 2015
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
K140881 · MBH
Orthopedic · 312d
Cleared Apr 03, 2014
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K133834 · KWS
Orthopedic · 107d
Cleared Dec 15, 2010
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K101996 · PHX
Orthopedic · 153d
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