Identity
- Trade Name
- ONUR MEDİKAL EUDAMED
- Device Name
- REDUCTION SPINAL PEDICLE SCREWS FOR 6.0 MM ROD, TITANIUM EUDAMED
- Model / Reference
- SPINAL SCREW EUDAMED729-OM-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8698682058550K4 EUDAMED
- Basic UDI-DI
- B-8698682058550K4 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Spinal bone screw, non-bioabsorbable
Onur Medi̇kal by Onur Medikal Sanayi ve Ticaret Anonim Şirketi — Class IIb — CE/MDR — 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-8698682058550K4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Onur Medikal Sanayi ve Ticaret Anonim Şirketi
- EUDAMED SRN
- TR-MF-000016533
Sources (1)
- EUDAMED 4c119365-a150-4f47-b53d-4005b9a789b6 61 fields · synced Oct 7, 2026