Identity
- Device Name
- 4U SPINAL ROD Ø:5.5 L:80mm EUDAMED
- Model / Reference
- 2300580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682376504874 EUDAMED
- Basic UDI-DI
- B-08682376504874 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Category: Spinal bone screw, non-bioabsorbable
4U SPINAL ROD Ø:5.5 L:80mm by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682376504874 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000040424
Sources (1)
- EUDAMED 900c85b0-2509-400d-8546-30c3c2423a6e 61 fields · synced Oct 6, 2026