Medical Device Manufacturer · IE , Ringaskiddy

Depuy Ireland UC - FDA 510(k) Cleared Devices

47 submissions · 47 cleared · Since 2018
47
Total
47
Cleared
0
Denied
46 devices
26-46 of 46
Cleared Oct 17, 2022
ATTUNE Revision Cones
K212746 · MBH
Orthopedic · 413d
Cleared Sep 06, 2022
EMPHASYS Acetabular System
K221636 · LPH
Orthopedic · 92d
Cleared Aug 31, 2022
INHANCETM Reverse Glenoid Peripheral Posts
K221467 · PHX
Orthopedic · 103d
Cleared Jul 22, 2022
C-Stem AMT LE Prosthesis
K220216 · JDI
Orthopedic · 177d
Cleared Jun 08, 2022
INHANCETM Hybrid Anatomic Glenoid Implant
K212933 · MBF
Orthopedic · 266d
Cleared Apr 21, 2022
INHANCE™ Reverse Shoulder System
K212737 · PHX
Orthopedic · 234d
Cleared Jan 18, 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
K213781 · MBH
Orthopedic · 46d
Cleared Sep 15, 2021
GLOBAL UNITE™ Platform Shoulder System
K212710 · PHX
Orthopedic · 20d
Cleared Aug 25, 2021
ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
K211609 · JWH
Orthopedic · 92d
Cleared Aug 05, 2021
EMPHASYS Femoral Stems
K211657 · LZO
Orthopedic · 69d
Cleared Jul 22, 2021
DELTA XTEND Reverse Shoulder System
K203694 · PHX
Orthopedic · 216d
Cleared May 20, 2021
Actis DuoFix Hip Prosthesis- Collarless
K210581 · MEH
Orthopedic · 83d
Cleared Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
K203532 · LZO
Orthopedic · 147d
Cleared Jan 14, 2021
VELYS™ Robotic-Assisted Solution
K202769 · OLO
Orthopedic · 115d
Cleared Dec 28, 2020
Attune Revision Sleeve LPS Femoral Adaptors
K202248 · JWH
Orthopedic · 140d
Cleared Nov 25, 2020
GLOBAL UNITE™ Platform Shoulder System
K202098 · PHX
Orthopedic · 119d
Cleared Nov 25, 2020
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and...
K202194 · MBH
Orthopedic · 112d
Cleared Sep 11, 2020
DePuy PINNACLE Dual Mobility Liner
K200854 · LPH
Orthopedic · 164d
Cleared Apr 16, 2020
SIGMA High Performance (HP) Partial Knee System
K193549 · HRY
Orthopedic · 118d
Cleared Jan 30, 2020
ATTUNE All-Polyethylene Tibia
K193057 · JWH
Orthopedic · 90d
Cleared Jan 11, 2018
GLOBAL UNITE Platform Shoulder System
K170748 · PHX
Orthopedic · 307d
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