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Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System
EUDAMEDFDA UDIClass III (EU MDR)
Ref PLT-1014
by Inion Oy
Identity
- Trade Name
- Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System EUDAMED2.0 mm Inion CPS® FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Device Name
- Inion CPS Plates EUDAMED4 hole plate, extended FDA UDI
- Model / Reference
- PLT-1014 EUDAMED1 FDA UDI
- Description
- 4 hole plate, extended FDA UDI
Identifiers
- Catalog Number
- PLT-1014 FDA UDI
- Primary DI / UDI-DI
- 06438408000539 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408000539 EUDAMED
- 510(k) Number
- K010352 FDA UDI
- FDA Product Code
- JEY FDA UDI
- EMDN Code
- P09120606 OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4760 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 CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-06438408000539 | 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 8bb3a4c7-9465-4a79-be03-c03183296fc8 61 fields · synced Aug 3, 2026
- FDA UDI 3d6ba0cc-6da4-43ea-b2ed-1fe5fc5f12e0 35 fields · synced May 25, 2026