Identity
- Trade Name
- Axial Connector EUDAMED
- Device Name
- AccelFix Spinal Fixation System (Sterile) EUDAMED
- Model / Reference
- 1002-6565S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061391893 EUDAMED
- Basic UDI-DI
- B-08800061391893 EUDAMED
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Axial Connector by L&K Biomed — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800061391893 | Class IIb | Active |
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Manufacturer
- Manufacturer
- L&K Biomed
- EUDAMED SRN
- KR-MF-000033200
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 25b896aa-3c83-4146-bc70-df8f50bd6203 61 fields · synced Jul 10, 2026