Identity
- Trade Name
- Inion FreedomScrew™ EUDAMEDFDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- Inion FreedomScrew EUDAMEDScrew 2.7 x 35 mm FDA UDI
- Model / Reference
- OSA-2735 EUDAMED1 FDA UDI
- Description
- Screw 2.7 x 35 mm FDA UDI
Identifiers
- Catalog Number
- OSA-2735 FDA UDI
- Primary DI / UDI-DI
- 06438408003233 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408003233 EUDAMED
- 510(k) Number
- K123672 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
- GMDN Term
- Bioabsorbable orthopaedic bone screw 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
MR Safe FDA UDI
Inion FreedomScrew™ 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-06438408003233 | 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 (2)
- EUDAMED 0bae9ff3-714d-407a-9727-88e97c964329 61 fields · synced Jul 12, 2026
- FDA UDI 8b2fddd7-c8e8-4217-a893-50d4da4b2b50 35 fields · synced May 30, 2026