TRIALTIS Spine System
by Medos International SARL EUDAMEDGUDID
Active
Ref 5560-72-5132SModel TriALTIS Spine System Connector
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10705034604596 | Date23 Feb 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number0705034a002586D | Date30 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- TRIALTIS Spine System EUDAMEDTrialtis GUDID
- Generic Name
- Bone-screw internal spinal fixation system connector
- Device Name
- Parallel connectors, Axial connectors, Lateral connectors
- Model / Ref / Catalog
- TriALTIS Spine System Connector, 5560-72-5132S, 5560725132S
- Primary DI / UDI-DI
- 10705034604596
- Basic UDI-DI
- 0705034a002586D
- 510(k) Number
- FDA Product Code
- NKB
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- GMDN Term
- Bone-screw internal spinal fixation system connector
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 888.3070
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000014268
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Medos International SARL
Properties
Other properties (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No