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Ligafix®
EUDAMEDFDA UDIClass I (EU MDR)
Ref LIG9000093Model Bone tap
by S.b.m. Sas
Identity
- Trade Name
- LIGAFIX® EUDAMEDLIGAFIX FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Bone tap for ACL reconstruction EUDAMEDBlack tap to be used with LIGAFIX interference screws of diameter 8, 9 and 10 mm, for ACL reconstruction. FDA UDI
- Model / Reference
- Bone tap EUDAMEDLIG9000093 EUDAMEDBlack tap for Ø 8, 9 & 10 mm screws FDA UDI
- Description
- Black tap to be used with LIGAFIX interference screws of diameter 8, 9 and 10 mm, for ACL reconstruction. FDA UDI
Identifiers
- Catalog Number
- LIG9000093 FDA UDI
- Primary DI / UDI-DI
- 03760154002264 EUDAMEDFDA UDI
- Basic UDI-DI
- 376015400DT2019046VT EUDAMED
- FDA Product Code
- HWX FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Bone tap, reusable 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 | 376015400DT2019046VT | 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 756ca82b-3a44-4ee2-8160-f6cfbfa87526 61 fields · synced Jul 22, 2026
- FDA UDI a830c8a4-6c9d-4e7d-8cb0-257b7baebcef 34 fields · synced May 30, 2026