SPII Model Lubinus Hip Stem
by Waldemar Link GmbH & Co. KG 175 variants
Ref 127-952/35Model Hip stem, cemented, CoCrMo, long stem prosthesis, XL neck, 135° CCD
Active
CE MDR
Valid until
16 May 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-HSP-003013-VY 04026575335824 | Date7 May 2026 | StatusActive |
Certificates
- 20399GB450240517 Active
Technical documentation EU MDR
- Certifier
- DNV MEDCERT GmbH 0482
- Issued
- 17 May 2024
- Expires
- 16 May 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SPII Model Lubinus Hip Stem
- Model / Reference
- Hip stem, cemented, CoCrMo, long stem prosthesis, XL neck, 135° CCD, 127-952/35
- Primary DI / UDI-DI
- 04026575335824
- Basic UDI-DI
- 4026575-1-HSP-003013-VY
- EMDN Code
- P090804030101 Revision cemented femoral stems, with fixed neck
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No