Jet-X

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Jet-X FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Device Name: JET-X LARGE - BAR MODULE FDA UDI
Model / Reference: 71067351 FDA UDI
Description: JET-X LARGE - BAR MODULE FDA UDI

Identifiers

Catalog Number: 71067351 FDA UDI
Primary DI / UDI-DI: 03596010607935 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

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

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 Conditional FDA UDI

Category: External orthopaedic fixation system, reusable

Jet-X by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
TransFx™ — Zimmer, Inc. · Class I
HOFFMANN — Stryker Corp. · Class II
SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · 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: Smith & Nephew, Inc.

Sources (1)

FDA UDI aa6be082-d791-4e6e-b458-fa6008732d89 35 fields · synced Jun 8, 2026