Identity
- Trade Name
- COX Monoaxial Pedicle Screw EUDAMED
- Device Name
- Posterior spinal screw-rod system EUDAMED
- Model / Reference
- FJD3 EUDAMED19900157 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939263885069 EUDAMED
- Basic UDI-DI
- B-06939263885069 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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
COX Monoaxial Pedicle Screw by Beijing Fule Science & Technology Development Co., Ltd. — Class IIb — MDD — 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-06939263885069 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000006511
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fcb0195d-8622-4f90-bf57-3a4149e376dc 61 fields · synced Jun 19, 2026