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Inion OTPS™ Fixation System
EUDAMEDClass III (EU MDR)
Ref FRF-1263Ref FRF-1044Ref FRF-1043Ref FRF-1051Ref FRF-1046Ref FRF-1222Ref FRF-1049Ref FRF-1042Ref FRF-1053
by Inion Oy
Identity
- Trade Name
- Inion OTPS™ Fixation System EUDAMED
- Device Name
- Inion OTPS Screws EUDAMEDInion OTPS Plates EUDAMED
- Model / Reference
- FRF-1263 EUDAMEDFRF-1044 EUDAMEDFRF-1043 EUDAMEDFRF-1051 EUDAMEDFRF-1046 EUDAMEDFRF-1222 EUDAMEDFRF-1049 EUDAMEDFRF-1042 EUDAMEDFRF-1053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438408010620 EUDAMED06438408010354 EUDAMED06438408010347 EUDAMED06438408005633 EUDAMED06438408010378 EUDAMED06438408006142 EUDAMED06438408010408 EUDAMED06438408010330 EUDAMED06438408005657 EUDAMED
- Basic UDI-DI
- B-06438408010620 EUDAMEDB-06438408010354 EUDAMEDB-06438408010347 EUDAMEDB-06438408005633 EUDAMEDB-06438408010378 EUDAMEDB-06438408006142 EUDAMEDB-06438408010408 EUDAMEDB-06438408010330 EUDAMEDB-06438408005657 EUDAMED
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMEDP09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS 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 OTPS™ Fixation 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-06438408010620 | Class III | Active |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (9)
- EUDAMED 7b40b133-0900-4e8a-b0d6-cf271a95d5c4 61 fields · synced Aug 4, 2026
- EUDAMED 23556a8e-66ce-4991-8cc3-8ea8eacb9ba5 61 fields · synced May 17, 2026
- EUDAMED 1d6edc2e-14de-4ac9-b20d-61e619882325 61 fields · synced May 17, 2026
- EUDAMED c16e04a1-3137-46c2-a7fe-8b94e9167024 61 fields · synced May 17, 2026
- EUDAMED 07534fce-a367-4354-965b-4dd3c27a4e21 61 fields · synced May 18, 2026
- EUDAMED 9dfce66a-cd83-426e-b565-442afef5f976 61 fields · synced May 18, 2026
- EUDAMED 2be6ce3f-1319-4f8b-8b16-467e1c08dae0 61 fields · synced May 18, 2026
- EUDAMED 3d780f6d-6250-40a2-b09c-343507229534 61 fields · synced May 18, 2026
- EUDAMED cd85b90f-0df0-4d00-a8b5-1e104d9175c1 61 fields · synced May 19, 2026