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Inion FixOn™ Biocomposite Suture Anchor
EUDAMEDClass III (EU MDR)
Ref FOB-6503Ref FOB-5502Ref FOB-6501Ref FOB-5501Ref FOB-4502Ref FOB-6502Ref FOB-5503
by Inion Oy
Identity
- Trade Name
- Inion FixOn™ Biocomposite Suture Anchor EUDAMED
- Device Name
- Inion FixOn Biocomposite Suture Anchor EUDAMED
- Model / Reference
- FOB-6503 EUDAMEDFOB-5502 EUDAMEDFOB-6501 EUDAMEDFOB-5501 EUDAMEDFOB-4502 EUDAMEDFOB-6502 EUDAMEDFOB-5503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408007835 EUDAMED06438408007798 EUDAMED06438408007811 EUDAMED06438408007781 EUDAMED06438408007767 EUDAMED06438408007828 EUDAMED06438408007804 EUDAMED
- Basic UDI-DI
- B-06438408007835 EUDAMEDB-06438408007798 EUDAMEDB-06438408007811 EUDAMEDB-06438408007781 EUDAMEDB-06438408007767 EUDAMEDB-06438408007828 EUDAMEDB-06438408007804 EUDAMED
- EMDN Code
- P09120102 ANCHORS, TENDON AND LIGAMENT SYNTHESIS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland 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: Hand-held surgical retractor, reusable
Inion FixOn™ Biocomposite Suture Anchor by Inion Oy — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand-held surgical retractor, reusable.
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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-06438408007835 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (7)
- EUDAMED 88c986d7-1a27-45fe-b4f3-4e705d8536d9 61 fields · synced Jul 31, 2026
- EUDAMED 8a4d0d73-6e76-4f99-9d35-e1f12000e2d7 61 fields · synced May 16, 2026
- EUDAMED e9e3cad2-98b8-4a9e-be96-03d4aa2e94a7 61 fields · synced May 17, 2026
- EUDAMED cf160d3e-715c-4738-a081-d5144bc058c2 61 fields · synced May 17, 2026
- EUDAMED d8c841e3-4933-4dfe-98e4-b9dab02d0959 61 fields · synced May 18, 2026
- EUDAMED 736afe89-758f-498b-9fe1-c5f6ec603c20 61 fields · synced May 18, 2026
- EUDAMED bb0b3b5d-242d-445c-94f6-a41d4259ccae 61 fields · synced May 19, 2026