Inion Oy
FI-MF-000000646 · Finland · Tampere
Inion Oy is registered in the European database on medical devices as a manufacturer, with 1 053 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 512 |
|---|---|
| Class I | 540 |
| Class IIb | 1 |
Most frequent device types declared: ACC-9805, ACC-9831, BRS-5497, FRF-1014, IFS-9064.
Among these devices, 544 are declared sterile, 539 implantable, 510 reusable, 55 with a measuring function.
Devices declared under this manufacturer
- Inion BioRestore™ Sahara
- Inion ACL Instrumentation
- Inion CPS/OTPS instrumentation
- Inion CompressOn screw instrumentation
- Inion FixOn™ Biocomposite Suture Anchor
- Inion FreedomPin Instrumentation
- Inion FreedomPin™
- Inion FreedomScrew Instrumentation
- Inion FreedomScrew™
- Inion OTPS Pin Instruments
- Inion OTPS™ Mini Plating System
- Inion S-1™ Biodegradable Anterior Cervical Fusion System
Showing 12 of 1 053 declared devices.
Catalogue references include ACC-9805, BRS-5497, FRF-1014, INS-9011, INS-9242, INS-9331.
European nomenclature codes declared: P09120606, L091001, L098003, P900402, P09120503, L091002.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | INION OY (FI) · FDA 9710629 |
| Devices in EUDAMED | 1 053 |
| Country of registration | Finland |
Device-level evidence
| Devices with a numeric GTIN | 1 053 |
|---|---|
| Found in the U.S. device database | 932 |
| Share | 88.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INION OY |
North American profile: Both markets. Inion Oy is registered in both the United States and Canada.