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Inion OTPS™ Pin
EUDAMEDFDA UDIClass III (EU MDR)
Ref SET-1550Ref PIN-2040Ref SET-2050
by Inion Oy
Identity
- Trade Name
- Inion OTPS™ Pin EUDAMED2.0 mm Inion OTPS™ FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Device Name
- Inion OTPS Pin EUDAMED2.0 x 40 mm pin FDA UDI
- Model / Reference
- SET-1550 EUDAMEDPIN-2040 EUDAMEDSET-2050 EUDAMED1 FDA UDI
- Description
- 2.0 x 40 mm pin FDA UDI
Identifiers
- Catalog Number
- PIN-2040 FDA UDI
- Primary DI / UDI-DI
- 06438408010781 EUDAMED06438408006074 EUDAMEDFDA UDI06438408010798 EUDAMED
- Basic UDI-DI
- B-06438408010781 EUDAMEDB-06438408006074 EUDAMEDB-06438408010798 EUDAMED
- 510(k) Number
- K050275 FDA UDI
- FDA Product Code
- HTY FDA UDI
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
- GMDN Term
- Orthopaedic bone pin, bioabsorbable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Inion OTPS™ Pin by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408010781 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED 59a6e38c-b17b-448a-a69a-090d81ad07b0 61 fields · synced Sep 17, 2026
- EUDAMED 08abdf6d-13b3-465b-860f-dab0cf6db51d 61 fields · synced May 17, 2026
- EUDAMED 0f57cc50-ecde-4fe1-b522-05aa43b78d5b 61 fields · synced May 18, 2026
- FDA UDI f1f2b574-d976-474a-89ba-e822d1621d7e 35 fields · synced May 30, 2026