LINK Embrace Shoulder System
by Waldemar Link GmbH & Co. KG
Ref 645-077/15Model Bone screw, uncemented, Ti6Al4V, central cancellous
Active
CE MDR
Valid until
12 Sep 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4026575-1-OEX-300041-WN 04026575285846 | Date10 Aug 2026 | StatusActive |
Certificates
- 057-00-02-MDR Active
Technical documentation EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 13 May 2025
- Expires
- 12 Sep 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- LINK Embrace Shoulder System
- Model / Reference
- Bone screw, uncemented, Ti6Al4V, central cancellous, 645-077/15
- Primary DI / UDI-DI
- 04026575285846
- Basic UDI-DI
- 4026575-1-OEX-300041-WN
- EMDN Code
- P09018001 Shoulder prostheses fixing screws
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005215
Other devices from Waldemar Link GmbH & Co. KG
Properties
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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