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Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System
EUDAMEDFDA UDIClass III (EU MDR)
Ref SCR-1205Ref PLT-1027Ref TCK-1516Ref SCR-1201Ref SCR-1200Ref SCR-1202Ref SCR-1203
by Inion Oy
Identity
- Trade Name
- Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System EUDAMED2.5 mm Inion CPS® FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Device Name
- Inion CPS Screws EUDAMEDInion CPS Plates EUDAMEDInion CMF Rapid Tack EUDAMEDInion CPS Baby Screws EUDAMED8 hole plate FDA UDI
- Model / Reference
- SCR-1205 EUDAMEDPLT-1027 EUDAMEDTCK-1516 EUDAMEDSCR-1201 EUDAMEDSCR-1200 EUDAMEDSCR-1202 EUDAMEDSCR-1203 EUDAMED1 FDA UDI
- Description
- 8 hole plate FDA UDI
Identifiers
- Catalog Number
- PLT-1027 FDA UDI
- Primary DI / UDI-DI
- 06438408000850 EUDAMED06438408000669 EUDAMEDFDA UDI06438408002915 EUDAMED06438408000812 EUDAMED06438408000805 EUDAMED06438408000829 EUDAMED06438408000836 EUDAMED
- Basic UDI-DI
- B-06438408000850 EUDAMEDB-06438408000669 EUDAMEDB-06438408002915 EUDAMEDB-06438408000812 EUDAMEDB-06438408000805 EUDAMEDB-06438408000829 EUDAMEDB-06438408000836 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-06438408000850 | 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 (8)
- EUDAMED 1597563c-2209-4cf2-a1a1-e4d8a96027bf 61 fields · synced Aug 1, 2026
- EUDAMED c7ecbfde-5e3a-4c83-ada8-33bcf6d854db 61 fields · synced May 17, 2026
- EUDAMED 0baa46ea-c042-48c5-b5d6-25fd4f6e0ca7 61 fields · synced May 17, 2026
- EUDAMED c19e0bbe-25f5-435d-bee2-705b4d7a3c54 61 fields · synced May 18, 2026
- EUDAMED 8240cad4-ed29-4f1b-9d27-dc77c9c78faa 61 fields · synced May 18, 2026
- EUDAMED d59da837-570b-4d30-b49f-a588992539e6 61 fields · synced May 18, 2026
- EUDAMED 04dd44a4-388a-4c0c-967c-212bb3bfb8c3 61 fields · synced May 18, 2026
- FDA UDI 517cf485-ece6-4416-ab44-04615c83edc9 35 fields · synced May 30, 2026