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Inion CompressOn screw instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9005
by Inion Oy
Identity
- Trade Name
- Inion CompressOn screw instrumentation EUDAMEDInion CompressOn™ Instrument FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Inion CompressOn Screw instrumentation EUDAMEDInion Instruments EUDAMEDScrewdriver shaft, T15 FDA UDI
- Model / Reference
- IFS-9005 EUDAMED1 FDA UDI
- Description
- Screwdriver shaft, T15 FDA UDI
Identifiers
- Catalog Number
- IFS-9005 FDA UDI
- Primary DI / UDI-DI
- 06438408008009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408008009 EUDAMED6438408INION-IR-INSTRUM9T EUDAMED
- Direct Marketing DI
- 06438408008009 EUDAMED
- 510(k) Number
- K203105 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion CompressOn screw instrumentation by Inion Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408008009 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408008009 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED 912f3956-89bf-476e-bab2-c3075bec1b03 61 fields · synced Jun 19, 2026
- EUDAMED 913a9e6a-d64b-4e6f-abd9-8d9032bf3d5d 61 fields · synced May 17, 2026
- FDA UDI f8687ca6-36fa-4e62-82c9-2ef0d366e4cb 35 fields · synced May 30, 2026
- EUDAMED 58ff75f8-b727-42a2-b22e-bc114094c75e 61 fields · synced Jun 19, 2026