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Inion FreedomScrew™
EUDAMEDFDA UDIClass III (EU MDR)
Ref OSA-2020Ref OSC-4590Ref OSC-3545Ref OSC-3530Ref OSA-2740
by Inion Oy
Identity
- Trade Name
- Inion FreedomScrew™ EUDAMEDFDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- Inion FreedomScrew EUDAMEDScrew 4.5 x 90 mm, cannul. FDA UDIScrew 3.5 x 30 mm, cannul. FDA UDIScrew 2.0 x 20 mm FDA UDIScrew 3.5 x 45 mm, cannul. FDA UDIScrew 2.7 x 40 mm FDA UDI
- Model / Reference
- OSA-2020 EUDAMEDOSC-4590 EUDAMEDOSC-3545 EUDAMEDOSC-3530 EUDAMEDOSA-2740 EUDAMED1 FDA UDI
- Description
- Screw 4.5 x 90 mm, cannul. FDA UDIScrew 3.5 x 30 mm, cannul. FDA UDIScrew 2.0 x 20 mm FDA UDIScrew 3.5 x 45 mm, cannul. FDA UDIScrew 2.7 x 40 mm FDA UDI
Identifiers
- Catalog Number
- OSC-4590 FDA UDIOSC-3530 FDA UDIOSA-2020 FDA UDIOSC-3545 FDA UDIOSA-2740 FDA UDI
- Primary DI / UDI-DI
- 06438408003158 EUDAMEDFDA UDI06438408003608 EUDAMEDFDA UDI06438408003509 EUDAMEDFDA UDI06438408003530 EUDAMEDFDA UDI06438408003240 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408003158 EUDAMEDB-06438408003608 EUDAMEDB-06438408003530 EUDAMEDB-06438408003509 EUDAMEDB-06438408003240 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-06438408003158 | 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 (10)
- EUDAMED 6d89e385-c667-4abb-98fa-613ec28b37a8 61 fields · synced Aug 3, 2026
- FDA UDI 7fb4448d-e612-4b9b-af4a-2560ee49ee2e 35 fields · synced May 30, 2026
- FDA UDI e31f8491-b095-412b-874f-83df819a67cc 35 fields · synced May 30, 2026
- FDA UDI 3c097fad-c140-469b-956c-81915355c6aa 35 fields · synced May 30, 2026
- FDA UDI 61ad5575-a4b7-490f-a17d-6ab17d925a4d 35 fields · synced May 30, 2026
- FDA UDI 9cf6b9a4-0b3b-4212-b731-a206af6e40ef 35 fields · synced May 30, 2026
- EUDAMED e96d29e5-86f8-4767-b330-7b1fd82532b5 61 fields · synced Jul 12, 2026
- EUDAMED c3154124-166c-494d-bab3-a2ad0647b932 61 fields · synced Jul 18, 2026
- EUDAMED 7d6d2b6a-38a9-4c04-aef7-7b0321a7b11e 61 fields · synced Jul 25, 2026
- EUDAMED d845071f-8ce3-49c6-981c-8fe77c6eea35 61 fields · synced Aug 3, 2026