Triax

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: TRIAX FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Device Name: Carbon Tube; Blue FDA UDI
Model / Reference: 5150-2-401 FDA UDI
Description: Carbon Tube; Blue FDA UDI

Identifiers

Catalog Number: 5150-2-401 FDA UDI
Primary DI / UDI-DI: 07613327078985 FDA UDI
510(k) Number: K963614 FDA UDI
FDA Product Code: JEC FDA UDI
GMDN Term: External orthopaedic fixation system, reusable 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

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

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

Dimensions & Sizes

Size: Length — 350.0 Millimeter FDA UDI

Category: External orthopaedic fixation system, reusable

Triax by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, reusable.

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
SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
SIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II

Cleared under the same submission

K963614 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: Stryker Corp.

Sources (1)

FDA UDI 9f67951e-eabe-4a68-aba1-91ea3bfa4871 36 fields · synced May 30, 2026