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Onur Medi̇kal
EUDAMEDClass IIb (EU MDR)
Ref 755-OM-270Model TRANSVERSE CONNECTOR
Identity
- Trade Name
- ONUR MEDİKAL EUDAMED
- Device Name
- TRANSVERSE CONNECTOR 70-80 MM, TITANIUM EUDAMED
- Model / Reference
- TRANSVERSE CONNECTOR EUDAMED755-OM-270 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8698682065350JG EUDAMED
- Basic UDI-DI
- B-8698682065350JG EUDAMED
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS 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: Bone-screw internal spinal fixation system connector
Onur Medi̇kal by Onur Medikal Sanayi ve Ticaret Anonim Şirketi — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- USS — Synthes GmbH · Class IIb
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- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, 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-8698682065350JG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Onur Medikal Sanayi ve Ticaret Anonim Şirketi
- EUDAMED SRN
- TR-MF-000016533
Sources (1)
- EUDAMED 0f07a61c-2696-4974-b7e5-c887cf2bf78b 61 fields · synced Oct 7, 2026