Vantage

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Vantage FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: 3D/3D+ Alignment Rod FDA UDI
Model / Reference: 03-CNB-AR-0000 FDA UDI
Description: 3D/3D+ Alignment Rod FDA UDI

Identifiers

Catalog Number: 03-CNB-AR-0000 FDA UDI
Primary DI / UDI-DI: 10885862628008 FDA UDI
510(k) Number: K230717 FDA UDI
FDA Product Code: HSN FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 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: Osteotomy guide, reusable

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

Similar devices

Also classified as Osteotomy guide, reusable.

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Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

Cleared under the same submission

K230717 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: Exactech, Inc.

Sources (1)

FDA UDI 5327dac8-f95c-4246-8924-5a5eada52e6f 35 fields · synced Jun 8, 2026