USTAR II Knee System
by United Orthopedic Corporation
Ref 2515-1409
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04719872153580 04719872153580 | Date30 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- USTAR II Knee System Cemented Curved Stem, RHS, Ti Plasma Spray, 9mm Dia., 200mm Stem Length
- Model / Reference
- 2515-1409
- Primary DI / UDI-DI
- 04719872153580
- Basic UDI-DI
- B-04719872153580
- EMDN Code
- P090906 Knee prostheses for large resections
- Device Class
- Class III
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- TW-MF-000009523
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from United Orthopedic Corp.
Properties
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