Vantage PSI

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name: Vantage PSI FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides. FDA UDI
Model / Reference: Fluoroscopic Insert FDA UDI
Description: Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides. FDA UDI

Identifiers

Catalog Number: 351-80-11 FDA UDI
Primary DI / UDI-DI: 00816847022606 FDA UDI
510(k) Number: K193432 FDA UDI
FDA Product Code: OYK 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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 25 Millimeter FDA UDI

Category: Osteotomy guide, reusable

Vantage PSI by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
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

K193432 also covers:

Vantage PSI — 3D SYSTEMS, INC.
Vantage PSI — 3D SYSTEMS, INC.

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: 3d Systems, Inc.

Sources (1)

FDA UDI a3a0d6cf-8b43-414a-836c-60df1da45f93 37 fields · synced May 30, 2026