GEMINI SL Total Knee System
by Waldemar Link GmbH & Co. KG 247 variants
Ref 318-803/14Model Articulating surface, vitamin E highly crosslinked UHMWPE, mobile bearing
Active
CE MDR
Valid until
17 Jan 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-KNP-200022-UF 04026575179398 | Date25 Jun 2026 | StatusActive |
Certificates
- 13803GB450251029 Active
Technical documentation EU MDR
- Certifier
- DNV MEDCERT GmbH 0482
- Issued
- 29 Oct 2025
- Expires
- 17 Jan 2029
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- GEMINI SL Total Knee System
- Model / Reference
- Articulating surface, vitamin E highly crosslinked UHMWPE, mobile bearing, 318-803/14
- Primary DI / UDI-DI
- 04026575179398
- Basic UDI-DI
- 4026575-1-KNP-200022-UF
- EMDN Code
- P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
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