Identity
- Trade Name
- P.F.C. FDA UDI
- Generic Name
- Knee arthroplasty wedge FDA UDI
- Device Name
- Wedges EUDAMEDP.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2.5 10 DEGREE 16mm FDA UDI
- Model / Reference
- PFC Sigma Wedges EUDAMED86-0382 EUDAMEDFDA UDI
- Description
- P.F.C. MODULAR PLUS TIBIAL FULL WEDGE CEMENTED 2.5 10 DEGREE 16mm FDA UDI
Identifiers
- Catalog Number
- 860382 FDA UDI
- Primary DI / UDI-DI
- 10603295216094 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004418Q EUDAMED
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P09098001 KNEE PROSTHESES AUGMENTS EUDAMED
- GMDN Term
- Knee arthroplasty wedge FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 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
Yes
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
Wedges 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 | 0603295a004418Q | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED 132d0b5c-0f78-4e93-9e33-674b5d7137c1 61 fields · synced Jun 18, 2026
- FDA UDI 36b00c6c-b3e5-40f2-98fa-f411ad479384 36 fields · synced May 30, 2026