Vantage

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Vantage FDA UDI
Generic Name: Ankle prosthesis trial, reusable FDA UDI
Device Name: LNR TRIAL-FB-SZ 3-R-7MM FDA UDI
Model / Reference: 351-22-13 FDA UDI
Description: LNR TRIAL-FB-SZ 3-R-7MM FDA UDI

Identifiers

Catalog Number: 351-22-13 FDA UDI
Primary DI / UDI-DI: 10885862609281 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Ankle prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

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

Dimensions & Sizes

Size: Height — 7 Millimeter FDA UDI

Category: Ankle prosthesis trial, reusable

Vantage by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ankle prosthesis trial, reusable.

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INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Cadence™ — Ascension Orthopedics, Inc. · Class I
Cadence™ — Ascension Orthopedics, Inc. · Class I
XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class I
Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

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: Exactech, Inc.

Sources (1)

FDA UDI 0b342fa3-8e3c-43ed-a108-22b052287530 35 fields · synced May 30, 2026