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Austofix Plate and Screw System
EUDAMEDClass IIb (EU MDR)
Ref 1049-00-06018LModel L&C Clavicle Hook Locking Plate (H18) | 6 Hole LEFT, 64mm
Identity
- Trade Name
- Austofix Plate and Screw System EUDAMED
- Model / Reference
- L&C Clavicle Hook Locking Plate (H18) | 6 Hole LEFT, 64mm EUDAMED1049-00-06018L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09339430019612 EUDAMED
- Basic UDI-DI
- B-09339430019612 EUDAMED
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
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
The Austofix Plate and Screw System is a medical device designed for fixation of clavicle fractures in adults. It is a Class IIb medical device, indicated for use as an emergency or alternative stabilization measure. The system consists of a plate and screw components that are secured to the affected area using sutures. This device has been evaluated for its safety and efficacy through rigorous testing and analysis.
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-09339430019612 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Australian Orthopaedic Fixations Pty. Ltd.
- EUDAMED SRN
- AU-MF-000009151
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e2ddf785-9b8a-4257-a094-b12940378b6a 61 fields · synced Oct 6, 2026