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Inion S-1™ Biodegradable Anterior Cervical Fusion System
EUDAMEDClass III (EU MDR)
Ref SPN-5112Ref SPN-5325Ref SPN-5116Ref SPN-5118Ref SPN-5111Ref SPN-5102Ref SPN-5117Ref SPN-5304Ref SPN-5322Ref SPN-5323Ref SPN-5100Ref SPN-5303Ref SPN-5302Ref SPN-5321Ref SPN-5110Ref SPN-5115
by Inion Oy
Identity
- Trade Name
- Inion S-1™ Biodegradable Anterior Cervical Fusion System EUDAMED
- Device Name
- Inion S-1 Plates EUDAMEDInion S-1 Screws EUDAMED
- Model / Reference
- SPN-5112 EUDAMEDSPN-5325 EUDAMEDSPN-5116 EUDAMEDSPN-5118 EUDAMEDSPN-5111 EUDAMEDSPN-5102 EUDAMEDSPN-5117 EUDAMEDSPN-5304 EUDAMEDSPN-5322 EUDAMEDSPN-5323 EUDAMEDSPN-5100 EUDAMEDSPN-5303 EUDAMEDSPN-5302 EUDAMEDSPN-5321 EUDAMEDSPN-5110 EUDAMEDSPN-5115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408006616 EUDAMED06438408006760 EUDAMED06438408006654 EUDAMED06438408006678 EUDAMED06438408006609 EUDAMED06438408010675 EUDAMED06438408006661 EUDAMED06438408010736 EUDAMED06438408006739 EUDAMED06438408006746 EUDAMED06438408010651 EUDAMED06438408010729 EUDAMED06438408010712 EUDAMED06438408006722 EUDAMED06438408006593 EUDAMED06438408006647 EUDAMED
- Basic UDI-DI
- B-06438408006616 EUDAMEDB-06438408006760 EUDAMEDB-06438408006654 EUDAMEDB-06438408006678 EUDAMEDB-06438408006609 EUDAMEDB-06438408010675 EUDAMEDB-06438408006661 EUDAMEDB-06438408010736 EUDAMEDB-06438408006739 EUDAMEDB-06438408006746 EUDAMEDB-06438408010651 EUDAMEDB-06438408010729 EUDAMEDB-06438408010712 EUDAMEDB-06438408006722 EUDAMEDB-06438408006593 EUDAMEDB-06438408006647 EUDAMED
- EMDN Code
- P09070199 SPINAL FUSION SYSTEMS - OTHER 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
Inion S-1™ Biodegradable Anterior Cervical Fusion System by Inion Oy — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06438408006616 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (16)
- EUDAMED effebfac-0518-4de9-a5c0-5f85746bb23c 61 fields · synced Oct 1, 2026
- EUDAMED 7eaf400c-184b-4ad9-9b01-cd6b43f80409 61 fields · synced May 16, 2026
- EUDAMED 49f97656-4bc5-4fd8-b766-e99b5dcb606a 61 fields · synced May 17, 2026
- EUDAMED 6f7e9cda-d7d6-4da8-8ccb-319343599d51 61 fields · synced May 17, 2026
- EUDAMED b1833a04-17b4-4164-84f9-cec87af9c9c5 61 fields · synced May 17, 2026
- EUDAMED 627d953c-a0e1-41a2-9e5c-cb0c282ee433 61 fields · synced May 17, 2026
- EUDAMED 06766c0b-fdb4-4a40-b65d-d1b9b9cf31e3 61 fields · synced May 17, 2026
- EUDAMED 102cc362-6834-470a-852e-915798e25963 61 fields · synced May 18, 2026
- EUDAMED 4872403a-1160-4780-8cce-1e3650b95934 61 fields · synced May 18, 2026
- EUDAMED 595cf23c-129d-4411-8d94-17bedde1f6cc 61 fields · synced May 18, 2026
- EUDAMED 9348307e-d435-4be7-9e39-21aae3c9ce04 61 fields · synced May 18, 2026
- EUDAMED a1d7b7ed-6df1-4350-9e99-ea8e834e0dc6 61 fields · synced May 18, 2026
- EUDAMED 708526ab-d47d-4509-bd8d-75ddb53d4df8 61 fields · synced May 18, 2026
- EUDAMED 6a89b964-e6dd-4b02-ac52-5e72c2b5c039 61 fields · synced May 18, 2026
- EUDAMED e00e5e2e-fb83-43ee-b664-8363e84aa6b1 61 fields · synced May 18, 2026
- EUDAMED b1ae11f8-17fd-4563-9de0-cf2882acc051 61 fields · synced May 19, 2026