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Ligafix®
EUDAMEDFDA UDIClass I (EU MDR)
Ref LIG9000051Model Stopper
by S.b.m. Sas
Identity
- Trade Name
- LIGAFIX® EUDAMEDLIGAFIX FDA UDI
- Generic Name
- Bone tunnel plug, non-cannulated FDA UDI
- Device Name
- Stopper for ACL reconstruction EUDAMEDLIGAFIX Stopper to be used with LIGAFIX interference screws in ACL reconstruction. FDA UDI
- Model / Reference
- Stopper EUDAMEDLIG9000051 EUDAMEDLIGAFIX Stopper FDA UDI
- Description
- LIGAFIX Stopper to be used with LIGAFIX interference screws in ACL reconstruction. FDA UDI
Identifiers
- Catalog Number
- LIG9000051 FDA UDI
- Primary DI / UDI-DI
- 03760154004046 EUDAMEDFDA UDI
- Basic UDI-DI
- 376015400DT2019049VZ EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone tunnel plug, non-cannulated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
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
Category: Surgical implant template, reusable
Ligafix® by S.b.m. Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376015400DT2019049VZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.b.m. Sas
- EUDAMED SRN
- FR-MF-000000214
Sources (2)
- EUDAMED 3491680c-4979-4a67-a939-6d698e4a6408 61 fields · synced Jul 14, 2026
- FDA UDI 288ff364-cafd-4c2c-b1b5-b90e72fd8c30 34 fields · synced May 30, 2026