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4U SPINAL PEDICLE POSTERIOR MONOAXIAL SCREW Ø:4.5 L35mm
EUDAMEDClass IIb (EU MDR)
Ref 1304535
Identity
- Device Name
- 4U SPINAL PEDICLE POSTERIOR MONOAXIAL SCREW Ø:4.5 L35mm EUDAMED
- Model / Reference
- 1304535 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682376501835 EUDAMED
- Basic UDI-DI
- B-08682376501835 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 PEDICLE POSTERIOR MONOAXIAL SCREW Ø:4.5 L35mm by 4U Makina Medikal Otomotiv Sanayi ve Ticaret Ltd. Şti. — Class IIb — MDD — listed in EUDAMED
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- 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-08682376501835 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000040424
Sources (1)
- EUDAMED a85613be-6808-48e7-962e-1d9c79f5f282 61 fields · synced Oct 7, 2026