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Vantage

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Vantage FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
3D/3D+ AP Sizing Drill – ZH Connection FDA UDI
Model / Reference
03-CNB-DR-0001 FDA UDI
Description
3D/3D+ AP Sizing Drill – ZH Connection FDA UDI

Identifiers

Catalog Number
03-CNB-DR-0001 FDA UDI
Primary DI / UDI-DI
10885862631411 FDA UDI
510(k) Number
K230717 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Fluted surgical drill bit, single-use 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Fluted surgical drill bit, single-use

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

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Cleared under the same submission

K230717 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 2cd94a3b-4ea3-4405-8704-6aeb01702296 35 fields · synced May 30, 2026