Uss
Ref 498.159SModel Posterior Connectors for Spine Connector
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The USS (Synthes GmbH) device is a posterior parallel connector extension connector claw connector L-connector T-connector, designed for use in spine surgery. It features a self-testing capability and supports implantable devices, with an active status of zero. The device has undergone comprehensive testing and evaluation to ensure its safety and efficacy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00389K9 07611819966369 | Date8 Aug 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Posterior Connectors for Spine Connector, 498.159S
- Primary DI / UDI-DI
- 07611819966369
- Basic UDI-DI
- 7611819a00389K9
- EMDN Code
- P09070304 Spine fixation system connectors
- Device Class
- Class IIb
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
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