Identity
- Trade Name
- Traufix EUDAMEDTraufix osteosynthesis, osteotomy, and arthrodesis devices FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Placa ALP para tibia distal TIDIS izquierda titanio 9 orificios EUDAMEDALP titanium distal tibia plate TIDIS 9 holes left FDA UDI
- Model / Reference
- 111.09 EUDAMEDFDA UDI
- Description
- ALP titanium distal tibia plate TIDIS 9 holes left FDA UDI
Identifiers
- Catalog Number
- 111.09 FDA UDI
- Primary DI / UDI-DI
- 07506494212347 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07506494212347 EUDAMED
- 510(k) Number
- K201510 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Traufix by Fixier Sa De Cv — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07506494212347 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Fixier Sa De Cv
- EUDAMED SRN
- MX-MF-000031017
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cc4522db-b760-4a26-9716-012415e31e1a 61 fields · synced Jul 12, 2026
- FDA UDI 41eb1a86-a5ae-403e-b221-b393f2085d24 36 fields · synced May 30, 2026