TRIALTIS Spine System
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- TRIALTIS Spine System EUDAMEDTRIALTIS FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Lordosed Rod, Straight Rod, Straight Rod Hex Ends, Straight Rod BLT Viper End, Lordosed Rod BLT Viper End, Lordosed Rod BLT Hex End, Straight Rod Hex Viper End, Lordosed Rod Hex Viper End EUDAMEDTRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 65mm 5.5 FDA UDI
- Model / Reference
- TriALTIS Spine System Rod EUDAMED5560-55-3065TS EUDAMEDFDA UDI
- Description
- TRIALTIS Spine System Pre-Lordosed Rod Titanium Alloy Bevel Ends ø5.5mm x 65mm 5.5 FDA UDI
Identifiers
- Catalog Number
- 5560553065TS FDA UDI
- Primary DI / UDI-DI
- 10705034591360 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0025567 EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Spinal bone screw, non-bioabsorbable
TRIALTIS Spine System by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a0025567 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED 00492321-86a7-43aa-8bc0-cf13d28d7d54 61 fields · synced Jul 22, 2026
- FDA UDI b0203544-47ff-40c9-bdf8-b1ed644e73df 36 fields · synced May 30, 2026