Tfx / Traumafix

FDA UDI

Class II (US FDA UDI)

by Sintea Plustek, LLC

Identity

Trade Name: TFX / TRAUMAFIX FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Model / Reference: TFX-20S63 FDA UDI

Identifiers

Primary DI / UDI-DI: 08057432561595 FDA UDI
510(k) Number: K031154 FDA UDI
FDA Product Code: JDW FDA UDI
GMDN Term: Orthopaedic bone wire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic bone wire

Tfx / Traumafix by Sintea Plustek, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · Class II

Cleared under the same submission

K031154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sintea Plustek, LLC

Sources (1)

FDA UDI ec7735f0-bc1c-42a8-979f-7503ebbae977 33 fields · synced May 30, 2026