Identity
- Device Name
- Cervical Spinal Orthosis EUDAMED
- Model / Reference
- 30073 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00656204000478 EUDAMED
- Basic UDI-DI
- 065620491MM EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The Cervical Spinal Orthosis (CSO) is a high-level, self-adjusting cervical spine stabilization device designed for post-operative spinal procedures to provide stable and comfortable positioning of the cervical spine. This standard-of-care medical device meets FDA 510(k) clearance requirements and has been recognized as a Level I device by the Centers for Medicare & Medicaid Services.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 065620491MM | Class I | Active |
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Manufacturer
- Manufacturer
- Tiburon Medical Enterprises
- EUDAMED SRN
- US-MF-000012145
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (1)
- EUDAMED f6702268-19a3-42a2-9ac5-7f0c6b3c25c9 61 fields · synced Jun 20, 2026