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Vantage PSI Anatomical Model

by 3D Systems, Inc.

Vantage PSI Anatomical Model (351-80-90) is a custom-made organ/bone anatomy model (FDA Class II; FDA product code OYK, Ankle Arthroplasty Implantation System) made by 3D Systems, Inc., listed in FDA GUDID since 13 Nov 2020 (UDI-DI 00816847022590), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816847022590 UDI-DI Date13 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Vantage PSI
Generic name
Custom-made organ/bone anatomy model
Model / Ref / Catalog
Anatomical Model, 351-80-90
Primary DI / UDI-DI
00816847022590
FDA product code
OYK
GMDN term
Custom-made organ/bone anatomy model
Device class
Class II
Regulation number
888.3110
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe
Size
Length — 25 Millimeter

Related devices

Category: Custom-made organ/bone anatomy model

Similar devices

Other devices filed under FDA product code OYK (Ankle Arthroplasty Implantation System).

Other devices from 3D Systems, Inc.

See all devices from 3D Systems, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)