Instrument

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: INSTRUMENT FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Device Name: TRIATHLON REVISION INSTRUMENTS FEMORAL CONE AUGMENT TRIAL FDA UDI
Model / Reference: 5549-T-332 FDA UDI
Description: TRIATHLON REVISION INSTRUMENTS FEMORAL CONE AUGMENT TRIAL FDA UDI

Identifiers

Catalog Number: 5549-T-332 FDA UDI
Primary DI / UDI-DI: 07613327000184 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Category: Knee femur prosthesis trial, reusable

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

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Also classified as Knee femur prosthesis trial, reusable.

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VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, 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 II	Pending data

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Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 15fdc555-49e3-4f86-93f2-a966b0fd606d 35 fields · synced May 30, 2026