← Back to catalogue
Solution System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1257-35-000Model SOLUTION SYSTEM Peripheral Bone Screw
Identity
- Trade Name
- SOLUTION SYSTEM EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Peripheral Bone Screw EUDAMEDSOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 35mm FDA UDI
- Model / Reference
- SOLUTION SYSTEM Peripheral Bone Screw EUDAMED1257-35-000 EUDAMEDFDA UDI
- Description
- SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 35mm FDA UDI
Identifiers
- Catalog Number
- 125735000 FDA UDI
- Primary DI / UDI-DI
- 10603295019886 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004078Q EUDAMED
- FDA Product Code
- JDI FDA UDI
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3350 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Solution System by DePuy Ireland UC — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0603295a004078Q | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 76bc7d9d-9141-4f82-9d06-3d19b9dc73ff 61 fields · synced Jun 19, 2026
- FDA UDI e2ea07ff-662a-4716-9ccd-b9dcb3bd7fc9 35 fields · synced May 30, 2026