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Inion Trinion Biodegradable Meniscus screw
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref SET-3002Ref MRD-3010Model MRD-3010
by Inion Oy
Identity
- Trade Name
- Inion Trinion Biodegradable Meniscus screw EUDAMED
- Device Name
- Inion Trinion Biodegradable Meniscus screw EUDAMED
- Model / Reference
- SET-3002 EUDAMEDMRD-3010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408004612 EUDAMED06438408004605 EUDAMED
- Basic UDI-DI
- B-06438408004612 EUDAMEDB-06438408004605 EUDAMED
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
Inion Trinion Biodegradable Meniscus screw by Inion Oy — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031714 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06438408004612 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED 9425d317-2a92-4d86-a40d-7ae6c993b15d 61 fields · synced Aug 4, 2026
- EUDAMED 3df4f595-9b74-4305-8b51-b792f0aa6c36 61 fields · synced May 18, 2026
- FDA 510(k) K031714 1 fields · synced May 18, 2026