GLOBAL ICON Stemless Shoulder System
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- GLOBAL ICON Stemless Shoulder System EUDAMEDGLOBAL ICON FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- Osteotomy Guide, Reusable EUDAMEDGLOBAL ICON Stemless Shoulder System RESECTION GUIDE Size 7 FDA UDI
- Model / Reference
- Osteotomy Guide, Reusable EUDAMED2240-10-052 EUDAMEDFDA UDI
- Description
- GLOBAL ICON Stemless Shoulder System RESECTION GUIDE Size 7 FDA UDI
Identifiers
- Catalog Number
- 224010052 FDA UDI
- Primary DI / UDI-DI
- 10603295426929 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004288Y EUDAMED
- Direct Marketing DI
- 10603295426929 EUDAMED
- FDA Product Code
- PKC FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone cutting forceps, reusable
GLOBAL ICON Stemless Shoulder System by DePuy Ireland UC — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212683 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0603295a004288Y | Class I | Active |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (3)
- EUDAMED ec220d75-6265-4d9d-b5d0-f900e729d0f7 61 fields · synced Jul 23, 2026
- FDA UDI ede155d0-3494-40a5-af05-9f4463aa810d 35 fields · synced May 30, 2026
- FDA 510(k) K212683 1 fields · synced May 18, 2026