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Inion CompressOn screw Instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IFS-9004
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 Instruments EUDAMEDInion CompressOn Screw instrumentation EUDAMEDScrewdriver shaft, T8 FDA UDI
- Model / Reference
- IFS-9004 EUDAMED1 FDA UDI
- Description
- Screwdriver shaft, T8 FDA UDI
Identifiers
- Catalog Number
- IFS-9004 FDA UDI
- Primary DI / UDI-DI
- 06438408007996 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438408INION-IR-INSTRUM9T EUDAMEDB-06438408007996 EUDAMED
- Direct Marketing DI
- 06438408007996 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 — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438408INION-IR-INSTRUM9T | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438408INION-IR-INSTRUM9T | 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 d5b8fb61-77b1-418d-bb5f-ae70d5c45202 61 fields · synced Jun 19, 2026
- EUDAMED a67a6985-d34a-4bbc-bbc8-0ec9b8eb8fb7 61 fields · synced May 19, 2026
- FDA UDI 81af3348-8df2-4225-a03e-3c5a785c74d5 35 fields · synced May 30, 2026
- EUDAMED 66adca46-7790-4957-aa31-eff169d0fbfa 61 fields · synced Jun 14, 2026