FDA.reportPublic FDA data

Depuy Ireland UC

Matched from indexed company URL: DePuy Ireland UC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155162663015516266Depuy Ireland UC1N2026-01-01Loughbeg, Ringaskiddy Co. Cork Munster IE Munster

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2290541494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
2290541056179924P070026CERAMAX CERAMIC HIP SYSTEMMRA2010-12-23
2290541537633783K982918DEPUY C-STEM SYSTEMJDI1998-10-05
2290541745144948K963309APEX HOLE ELIMINATOR PSLPH1996-11-12
2290541263237939K961939S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)LPH1996-08-13
2290541077147520K954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8LPH1996-01-22
2290541383007550K940743UHMWPE COMPONENTS-CHANGE IN PACKAGINGKWY1995-09-18
2290541561113698K934412COATED ZT PROXIMAL SLEEVELPH1994-06-03
2290541116135170K910664MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.LWJ1992-04-01
2290541134863612K871867ELITE MODULAR HIP SYSTEMJDI1988-04-08
2290541699869505K871510MODIFIED PROFILE HIP PMMA CEMENT SPACERJDI1987-05-27
2290541203479195K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJDI1985-09-18
2290541226169041K800894DUPUY CEMENT RESTRICTOR TRIALS & INSTR.JDI1980-05-02
2290541837726442K253624INHANCE™ Reverse Shoulder SystemPHX2026-03-11
2290541310511411K253551VELYS™ Hip NavigationQIH2026-03-06
2290541253911469K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsJWH2025-11-19
2290541996316742K251292RECLAIM Monobloc Revision Femoral StemLZO2025-05-23
2290541838572998K243977EMPHASYS Acetabular SystemLPH2025-01-22
2290541720999318K243248INHANCE INTACT™PKC2024-12-23
2290541983348438K242871ATTUNE™ Revision Hinge KneeKRO2024-11-21
2290541512151596K242665DePuy ATTUNE™ Total Knee SystemOIY2024-11-01
2290541565423264K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;JWH2024-07-11
2290541534480248K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyMBH2024-06-18
2290541597881175K240639PINNACLETM Constrained Acetabular LinersKWZ2024-04-04
2290542024396136K240211VELYS Robotic-Assisted SolutionOLO2024-06-05
2290541999908055K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemKRO2024-03-21
2290541378887719K233227VELYS™ Robotic-Assisted SolutionOLO2023-12-14
2290541226553100K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyMBH2023-12-11
2290541836558053K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalMEH2024-01-19
2290541467145665K231526CORAIL Cemented Femoral StemKWY2023-12-19
2290541332658523K231522EMPHASYS™ Dual Mobility SystemLPH2024-02-15
2290541968490317K231516INHANCE™ Shoulder System, Sterile Single Use InstrumentationMBF2023-07-21
2290541165092892K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidMBF2023-11-13
2290541122374537K230295ATTUNE® Revision ConesMBH2023-03-10
2290541106865009K223211INHANCETM Shoulder System – Humeral Stems and StemlessPHX2022-12-02
2290541853508784K222296ARTICUL/EZE Ceramic HeadsLZO2023-01-06
2290541209156454K221636EMPHASYS Acetabular SystemLPH2022-09-06
2290541156492123K221467INHANCETM Reverse Glenoid Peripheral PostsPHX2022-08-31
2290541751817019K221462DePuy Reclaim Monobloc Revision Femoral StemLZO2022-10-21
2290541350161017K220830TrueBalance™ Surgical SystemONN2022-09-15
2290541024296391K220216C-Stem AMT LE ProsthesisJDI2022-07-22
2290541528293272K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPMBH2022-01-18
2290541521685714K212933INHANCETM Hybrid Anatomic Glenoid ImplantMBF2022-06-08
2290542050667467K212746ATTUNE Revision ConesMBH2022-10-17
2290541656484607K212737INHANCE™ Reverse Shoulder SystemPHX2022-04-21
2290541643450737K212710GLOBAL UNITE™ Platform Shoulder SystemPHX2021-09-15
2290541896324264K212683GLOBAL ICON Stemless Shoulder SystemPKC2022-01-19
2290541209254635K211657EMPHASYS Femoral StemsLZO2021-08-05
2290542036531261K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertJWH2021-08-25
2290541716232287K210581Actis DuoFix Hip Prosthesis- CollarlessMEH2021-05-20
2290541078590647K210167DELTA XTEND Reverse Shoulder SystemPHX2021-02-19
2290541972781572K203694DELTA XTEND Reverse Shoulder SystemPHX2021-07-22
2290541482810717K203532BI-MENTUM™ ALTRX® Dual Mobility LinerLZO2021-04-28
2290541814022928K203167DePuy Corail AMT Hip ProsthesisLZO2020-11-19
2290541546771452K203108Ignite Stemless Anatomic Shoulder SystemPKC2021-07-16
2290541475634412K202769VELYS™ Robotic-Assisted SolutionOLO2021-01-14
2290541032121223K202716Ignite Anatomic Shoulder SystemMBF2021-05-20
2290541773512545K202248Attune Revision Sleeve LPS Femoral AdaptorsJWH2020-12-28
2290541856276200K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP TechnologyMBH2020-11-25
2290541928500572K202098GLOBAL UNITE™ Platform Shoulder SystemPHX2020-11-25
2290541419104294K200854DePuy PINNACLE Dual Mobility LinerLPH2020-09-11
2290541464308165K193549SIGMA High Performance (HP) Partial Knee SystemHRY2020-04-16
2290541573027683K193057ATTUNE All-Polyethylene TibiaJWH2020-01-30
2290541371331879K192946DePuy Corail AMT Hip ProsthesisLZO2019-11-26
2290541531091537K192919Pinnacle Duofix HA Acetabular Cup ProsthesisLPH2019-11-26
2290541728461166K192855DELTA XTEND(TM) Reverse Shoulder SystemPHX2020-02-24
2290541333509039K192448Delta Xtend Revers Shoulder SystemPHX2019-10-04
2290541861367845K183077Delta Xtend Reverse Shoulder SystemPHX2019-05-17
2290542050340121K170806ATTUNE Cemented Tibial Base, Fixed BearingJWH2017-06-15
2290541409076165K170748GLOBAL UNITE Platform Shoulder SystemPHX2018-01-11
2290541886494978K160907DePuy Actis DuoFix Hip ProsthesisMEH2016-07-19
2290541309884721K150862DePuy Actis Duofox Hip ProsthesisMEH2015-09-25
2290542004058593K133834DEPUY GLOBAL UNITE SHOULDER SYSTEMKWS2014-04-03
2290541234894133K120174DEPUT DELTA XTEND REVERSE SHOULDERPHX2012-06-11
2290541244722575K102080DEPUY RECLAIM REVISION HIP SYSTEMLZO2010-11-23
2290541491703285K101996DEPUY GLOBAL UNITE SHOULDER SYSTEMPHX2010-12-15
2290541914445203K082239DEPUY C-STEM AMTJDI2008-08-29
2290541364167462K081620MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEMKWS2008-06-30
2290541919300293K073676DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUPPHX2008-01-29
2290541141358746K062250DELTA XTEND REVERSE SHOULDER SYSTEMPHX2007-02-02
2290541690313097K052472DEPUY GLOBAL SHOULDER CROSSLINK GLENOIDKWS2005-10-06
2290541225621081K042959DEPUY C-STEM AMT HIP PROSTHESISJDI2004-12-22
2290541789053766K013350MODIFICATION TO DEPUY C-STEM SYSTEMJDI2001-11-07
2290541002379245
2290541005126228
2290541030448231
2290541056016952
2290541081022463
2290541085776252
2290541111573509
2290541160359531
2290541174317442
2290541190570014
2290541213929095
2290541251053747
2290541270941603
2290541280810349
2290541306976916
2290541312089002
2290541358651161
2290541380944911
2290541385863193
2290541400898936
2290541411184221
2290541448068685
2290541456739312
2290541456909949
2290541466837280
2290541487001065
2290541490090988
2290541500585269
2290541503651462
2290541630053497
2290541636120150
2290541655464618
2290541698176744
2290541728037999
2290541729950765
2290541744545541
2290541770519975

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHX162026-03-11
LPH92025-01-22
JDI92022-07-22
LZO82025-05-23
JWH62025-11-19
MBH62024-06-18
MEH42024-01-19
MBF42023-11-13
PKC32024-12-23
OLO32024-06-05
KWS32014-04-03
KRO22024-11-21
KWY22023-12-19
QIH12026-03-06
OIY12024-11-01
KWZ12024-04-04
ONN12022-09-15
HRY12020-04-16
MRA12010-12-23
LWJ11992-04-01
NJL11985-04-12

PMN#

43 records. Showing 1-40. Next