Unitrax

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Unitrax FDA UDI
Generic Name: Uncoated hip femur prosthesis, one-piece FDA UDI
Device Name: Head Component FDA UDI
Model / Reference: 6942-5-051 FDA UDI
Description: Head Component FDA UDI

Identifiers

Catalog Number: 6942-5-051 FDA UDI
Primary DI / UDI-DI: 07613327032451 FDA UDI
FDA Product Code: KWL FDA UDI
GMDN Term: Uncoated hip femur prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 51.0 Millimeter FDA UDI

Category: Uncoated hip femur prosthesis, one-piece

Unitrax by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated hip femur prosthesis, one-piece.

CPT® — Zimmer, Inc. · Class II
Quadra C femoral stems — Medacta International · Class II
CPT® — Zimmer, Inc. · Class II
VerSys® Advocate® V-Lign® — Zimmer, Inc. · Class II
VerSys® Advocate® V-Lign® — Zimmer, Inc. · Class II
Quadra C femoral stems — Medacta International · Class II
VerSys® Advocate® V-Lign® — Zimmer, Inc. · Class II
Corin Austin Moore Fenestrated Prosthesis (Cobalt Chrome) — CORIN LTD · 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 II	Pending data

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI bf42ff6e-51e5-4dc6-a562-f78fc3a27b73 35 fields · synced May 30, 2026