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Inion ACL instrumentation
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9321
by Inion Oy
Identity
- Trade Name
- Inion ACL instrumentation EUDAMEDInion ACL™ Instrumentation FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Inion ACL instrumentation EUDAMEDInion Instruments EUDAMEDFemoral drill guide, 5mm offset FDA UDI
- Model / Reference
- INS-9321 EUDAMED1 FDA UDI
- Description
- Femoral drill guide, 5mm offset FDA UDI
Identifiers
- Catalog Number
- INS-9321 FDA UDI
- Primary DI / UDI-DI
- 06438408002700 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002700 EUDAMED6438408INION-IRM-INSTRUAF EUDAMED
- Secondary DI
- M224INS93219 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Yes
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 ACL 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-06438408002700 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002700 | 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 (3)
- EUDAMED f89341e2-91bd-444f-bab0-e16e57cdaaad 61 fields · synced Jun 19, 2026
- EUDAMED f4daf117-d3e0-4c1f-842f-154d8185d47c 61 fields · synced May 19, 2026
- FDA UDI 9a2f8f14-54f5-40fa-8f07-b2ffcf46936f 34 fields · synced May 30, 2026