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Traufix

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 112.16

by Fixier Sa De Cv

Identity

Trade Name
Traufix EUDAMED
Traufix osteosynthesis, osteotomy, and arthrodesis devices FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Tornillo de cortical titanio de 3.5 mm por 16 mm EUDAMED
3.5mm titanium cortex screw 16mm FDA UDI
Model / Reference
112.16 EUDAMEDFDA UDI
Description
3.5mm titanium cortex screw 16mm FDA UDI

Identifiers

Catalog Number
112.16 FDA UDI
Primary DI / UDI-DI
07506494212392 EUDAMEDFDA UDI
Basic UDI-DI
B-07506494212392 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 EUDAMED
Class 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
Sterilization Method
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

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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 74530bda-b2dc-4930-9074-5fb67db69906 61 fields · synced Jun 1, 2026
  • FDA UDI d58801eb-126f-45ae-9eb5-7df5c9f79b34 36 fields · synced May 30, 2026