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Onur Medi̇kal
EUDAMEDClass IIb (EU MDR)
Ref 714-OM-655Model SPINAL PEDICULAR SCREW
Identity
- Trade Name
- ONUR MEDİKAL EUDAMED
- Device Name
- POLYAXIAL PEDICLE SCREW, TITANIUM, D6, L55 FOR 6.0 MM ROD EUDAMED
- Model / Reference
- SPINAL PEDICULAR SCREW EUDAMED714-OM-655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8698682060188HU EUDAMED
- Basic UDI-DI
- B-8698682060188HU 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.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- 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-8698682060188HU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Onur Medikal Sanayi ve Ticaret Anonim Şirketi
- EUDAMED SRN
- TR-MF-000016533
Sources (1)
- EUDAMED 1ae91d46-c4fd-4245-a9da-704ef0daffef 61 fields · synced Oct 8, 2026