Identity
- Trade Name
- Traufix EUDAMEDTraufix osteosynthesis, osteotomy, and arthrodesis devices FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Tornillo de cortical ALP titanio de 5.0 mm por 28 mm EUDAMED5.0mm titanium cortex locking screw 28mm FDA UDI
- Model / Reference
- 108.28 EUDAMEDFDA UDI
- Description
- 5.0mm titanium cortex locking screw 28mm FDA UDI
Identifiers
- Catalog Number
- 108.28 FDA UDI
- Primary DI / UDI-DI
- 07506494212002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07506494212002 EUDAMED
- 510(k) Number
- K201510 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 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
Category: Orthopaedic bone screw (non-sliding)
Traufix by Fixier Sa De Cv — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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- PANGEA — Stryker Corp. · Class II
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-07506494212002 | 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 279adce6-f016-43ed-99f7-eae8a5366070 61 fields · synced May 30, 2026
- FDA UDI 81fe338c-e718-4555-8b8c-cf6e409d3473 36 fields · synced May 30, 2026