Identity
- Trade Name
- ONUR MEDİKAL EUDAMED
- Device Name
- PLAIN SPINAL ROD, DIA.6.0 MM L120 MM, TITANIUM EUDAMED
- Model / Reference
- SPINAL ROD EUDAMED742-OM-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8698682063042HL EUDAMED
- Basic UDI-DI
- B-8698682063042HL 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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
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-8698682063042HL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Onur Medikal Sanayi ve Ticaret Anonim Şirketi
- EUDAMED SRN
- TR-MF-000016533
Sources (1)
- EUDAMED 4dea744b-820b-446a-8b49-615c638edf57 61 fields · synced Oct 8, 2026