FDA Registration Active 🇮🇪 Ireland

Depuy Ireland UC

Reg #: 3015516266 · FEI: 3015516266 · Expires 2026
Products
80
Proprietary Names
303
Establishment Types
2
Classifications
80

Registration Details

Registration Name
Depuy Ireland UC
Registration Number
3015516266
FEI Number
3015516266
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Loughbeg, Ringaskiddy
City
Co. Cork Munster
Country
IE

Regulatory Submissions

510(k) Number
K200854
PMA Number
P070026

Owner / Operator

Firm Name
DePuy Synthes, Inc.
Operator Number
1818910
Address
700 Orthopaedic Drive
City
Warsaw
State
IN
Postal Code
46582
Country
US

US Agent

Business Name
DePuy Synthes
Contact Name
Patrick McCullagh
Address
700 Orthopaedic Drive
City
Warsaw
State
IN
ZIP
46582
Country
US
Phone
267 3005417

Products

Device Name Product Code
Probe HXB
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Cover, Shoe, Operating-Room FXP
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Clamp HXD
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
Gouge, Surgical, General & Plastic Surgery GDH
Bone Cement LOD
Bone Cement, Antibiotic MBB
Tamp HXG
Rasp HTR
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
File HTP
Orthopedic Stereotaxic Instrument OLO
Trephine HWK
Osteotome HWM
Instrument, Compression HWN
Accessory, Surgical Apparel LYU
Instruments Designed For Press-Fit Osteochondral Implants QBO
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Driver, Prosthesis HWR
Instrument, Cutting, Orthopedic HTZ
Reamer HTO
Retractor GAD
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
Mallet, Surgical, General & Plastic Surgery GFJ
Bone Mill LYS
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
Guide, Surgical, Instrument FZX
Tape, Measuring, Rulers And Calipers FTY
Wire, Surgical LRN
Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Screw, Fixation, Bone HWC
Awl HWJ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Tray, Surgical, Instrument FSM
Extractor HWB
Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
Prosthesis, Elbow, Semi-Constrained, Cemented JDB
Cement Obturator LZN
Screwdriver HXX
Pusher, Socket HXO
Hammer, Surgical FZY
Template HWT
Hook, Bone KIK
Orthopedic Manual Surgical Instrument LXH
Wrench HXC
Intraoperative Orthopedic Joint Assessment Aid ONN
Goniometer, Nonpowered KQW
Impactor HWA
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Gauge, Depth HTJ
Forceps, General & Plastic Surgery GEN
Dispenser, Cement KIH
Automated Radiological Image Processing Software QIH
System, Image Processing, Radiological LLZ
Chisel, Surgical, Manual FZO
Bit, Drill HTW
Broach HTQ
Curette HTF
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
Dress, Surgical FYE
Punch, Surgical LRY

Proprietary Names

Proxima TELIGEN Mitek PROBE PINNACLE Dual Mobility OPERATING-ROOM (MULTIPLE BRANDS) SHOE DELTA XTEND Reverse Shoulder System INHANCE Shoulder System EMPHASYS Femoral Stems Clamp for Joint Recon Reclaim (hip) Apex (hip) Global Unite Platform Shoulder System Short Stem S-Rom (hip) Gouge instrumnts for Joint Recon Joint Ortho Tamp Instrument Elite (hip) Rasp for Joint Recon RASP S-ROM™ NOILES™ Rotating Hinge Knee System DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves ATTUNE™ Revision Knee System DePuy SIGMA™ Total Knee Prosthesis DePuy P.F.C. ™ SIGMA™ Total Knee Prosthesis DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components Instrument file for Joint Recon Trephine Global (Shoulder) DePuy GLOBAL UNITE Shoulder System various osteotome general instruments C-Stem (hip), Articul/eze compression instrument for Joint Recon Viper Prime ARICULATED TENSION DEVICE SYNTHES TEN ATTUNE All Polyethylene Tibia SURGICAL APPAREL (MULTIPLE BRANDS) ACCESSORY ATTUNE Medial Stabilized Fixed Bearing Insert various prosthesis drivers ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER Joint Recon Cutting Instrument Orthopaedic REAMER ATTUNE REVISION RP CONICAL REAMER Instrument Retractors Global Shoulder ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) PNS C-Stem AMT (hip), Articul/eze Joint Recon Mallet instruments Delta (shoulder) PINNACLE DUOFIX® Acetabular Cup Lere ATTUNE® Porous Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP Technology ATTUNE® Porous Medialized Dome Patella with AFFIXIUM™ 3DP Technology ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm ATTUNE REVISION RP BASE TRIAL SIZE 4 ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 3 ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm ATTUNE REVISION RP BASE TRIAL SIZE 6 ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 8 ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm ATTUNE REVISION RP BASE TRIAL SIZE 10 ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM ATTUNE Revision Tibial Sleeve 29 mm Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 9 ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 2 ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM ATTUNE REVISION RP STEM ADAPTOR TRIAL ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm ATTUNE REVISION RP BASE TRIAL SIZE 7 ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm ATTUNE REVISION RP BASE TRIAL SIZE 5 ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM TRUMATCH Personalized Solutions ATTUNE® Revision Knee System LCS, New Jersey Total Knee SIGMA® High Performance Partial Knee System Orthopaedic GUIDE Guide, Surgical, Instrument tape, measuring, rulers and calipers for Joint Recon measuring Delta Xtend (shoulder) Joint Recon Awl instruments instrument tray, instrument case ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE ATTUNE REVISION TIBIAL BROACH CADDY ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE Orthopaedic EXTRACTOR ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR Attune Enduron, Hylamer Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic Screwdrivers for Joint Recon PUSHER SOCKET Joint Recon Hammers VARIOUS TYPES OF HAMMERS C-Stem (Hip) templates guides Joint Recon Bone Hook Instrument broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc. Pinnacle ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 ATTUNE REVISION FEMORAL IM ADAPTOR ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6 wrenches for Joint Recon ATTUNE REVISION FEMORAL STRAIGHT STEM WRENCH ATTUNE Revision Sleeve LPS Femoral Adaptors ATTUNE Medial Stabilized Fixed Bearing (MS FB) Inserts joint recon Goniometers, nonpowered C-Stem (hip) Cement Restrictor Impactor Instruments (Joint Recon) Bengal Expedium Viper Concorde Joint Recon Surgical instrument motors and accessories/attachments WILLIAMS GAUGES Global Unite (shoulder) Acclaim Global Advantage Charnley various cement dispensers DePuy Corail AMT Hip Prosthesis Global (shoulder) ATTUNE Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP Technology Joint Recon instrument -chisel, surgical, manual spine instrument Orthopaedic DRILL DePuy GLOBAL UNITE Platform Shoulder System various broach instruments ATTUNE REVISION TIBIAL BROACH 45MM ATTUNE REVISION TIBIAL BROACH 61MM ATTUNE REVISION TIBIAL BROACH 37MM ATTUNE REVISION TIBIAL BROACH 29MM ATTUNE REVISION TIBIAL BROACH 53MM ATTUNE REVISION TIBIAL BROACH 69MM Joint Recon Curettes Actis (hip) Profile Life Liners Bone Punch, Tibial Punch, Femoral Punch, Acetabular Punch Punch, Surgical

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device