Inion Hexalon™ Biodegradable ACL/PCL Screw
EUDAMEDFDA UDIClass III (EU MDR)
by Inion Oy
Identity
- Trade Name
- Inion Hexalon™ Biodegradable ACL/PCL Screw EUDAMEDInion Hexalon™ ACL/PCL Screw FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- Inion Hexalon ACL/PCL Screw EUDAMEDACL/PCL screw 6 x 20 mm FDA UDI
- Model / Reference
- ACL-4113 EUDAMED1 FDA UDI
- Description
- ACL/PCL screw 6 x 20 mm FDA UDI
Identifiers
- Catalog Number
- ACL-4113 FDA UDI
- Primary DI / UDI-DI
- 06438408002397 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002397 EUDAMED
- 510(k) Number
- K071464 FDA UDI
- FDA Product Code
- JDR FDA UDIMAI FDA UDIHWC FDA UDI
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Tendon/ligament bone anchor, non-bioabsorbable
Inion Hexalon™ Biodegradable ACL/PCL Screw by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408002397 | 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 (2)
- EUDAMED 50611250-10cd-4d75-a69c-e34040b9d6ae 61 fields · synced Jun 8, 2026
- FDA UDI bfab5809-8124-4082-babc-db103cd43fda 35 fields · synced May 30, 2026