TransFx™

FDA UDI

Class I (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: TransFx™ FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Model / Reference: 4452-92-25 FDA UDI

Identifiers

Catalog Number: 00-4452-092-25 FDA UDI
Primary DI / UDI-DI: 00889024067257 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: External orthopaedic fixation system, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: External orthopaedic fixation system, reusable

An external orthopaedic fixation system designed to stabilize fractured bones, other than those in the vertebral column, promoting treatment and healing. This reusable device is used mainly for long bone fractures, joint fusions, limb lengthening, and other orthopedic procedures.

Similar devices

Also classified as External orthopaedic fixation system, reusable.

HOFFMANN — Stryker Corp. · Class II
ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
HOFFMANN — Stryker Corp. · Class II
SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
TENXOR — Stryker Corp. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI 3df984be-69e9-42c3-bcee-62165564674b 35 fields · synced Jul 2, 2026