Vantage PSI System— 510(k) K193432

Substantially Equivalent

3D Systems

FDA 510(k) clearance K193432 for Vantage PSI System, Substantially Equivalent on 2020-11-09. Applicant: 3D Systems. Device class: 2.

Clearance details

Applicant: 3D Systems
Product code: Code OYK
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2019-12-10
Decision date: 2020-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYK

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K243174 — Cadence Ankle PSI System2024-10-25
K241148 — Salto Talaris Ankle PSI System2024-08-30
K241326 — Cadence Ankle PSI System2024-08-30
K231585 — Vantage PSI System2023-06-30

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