Cemented FB Tibial Insert
by DePuy Ireland UC Ireland EUDAMED
Ref 1516-40-922Model ATTUNE Knee System Cemented FB Tibial Insert
EMDN P090903020202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0603295a002548P | Date4 Nov 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 755208 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 29 Jun 2026
- Expires
- 9 Jul 2029
- Reason
- Change approved
Specification
- Device Name
- Cemented FB Tibial Insert
- Model / Reference
- ATTUNE Knee System Cemented FB Tibial Insert, 1516-40-922
- Primary DI / UDI-DI
- 10603295050582
- Basic UDI-DI
- 0603295a002548P
- EMDN Code
- P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
- Device Class
- Class III
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000007377
Other devices from DePuy Ireland UC
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 10603295050582|0603295A002548P