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Inion CompressOn screw instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IFS-5008
by Inion Oy
Identity
- Trade Name
- Inion CompressOn screw instrumentation EUDAMEDInion CompressOn™ Instrument FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Inion CompressOn Screw instrumentation EUDAMEDInion Instruments EUDAMEDDrill tap Ø 5.0 mm, cannulated FDA UDI
- Model / Reference
- IFS-5008 EUDAMED1 FDA UDI
- Description
- Drill tap Ø 5.0 mm, cannulated FDA UDI
Identifiers
- Catalog Number
- IFS-5008 FDA UDI
- Primary DI / UDI-DI
- 06438408008085 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408008085 EUDAMED6438408INION-IIA-INSTRUUR EUDAMED
- Direct Marketing DI
- 06438408008085 EUDAMED
- 510(k) Number
- K203105 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class IIa 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 IIa — 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-06438408008085 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408008085 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (4)
- EUDAMED 3001a699-e656-4a76-a2c3-d3ceed0813c3 61 fields · synced Jul 13, 2026
- EUDAMED ac6b857f-91f1-4e10-ba4f-a5f3947da7e3 61 fields · synced May 17, 2026
- FDA UDI 1ae11307-78c6-4c77-9d64-c1f4d0b206db 35 fields · synced May 29, 2026
- EUDAMED 44fe89cd-d61a-40c2-b028-1f44addfd4a3 61 fields · synced Jun 19, 2026