Vantage PSI System— 510(k) K231585

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K231585 for Vantage PSI System, Substantially Equivalent on 2023-06-30. Applicant: 3D Systems, Inc.. Device class: 2.

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code OYK
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2023-05-31
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.