Salto Talaris Ankle PSI System— 510(k) K243173

Name: FDA 510(k) clearance K243173
Creator: U.S. Food and Drug Administration
Published: 2024-10-25

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K243173 for Salto Talaris Ankle PSI System, Substantially Equivalent on 2024-10-25. 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: 2024-09-30
Decision date: 2024-10-25
Decision: Substantially Equivalent
Clearance type: Special
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
K223326 — Axiom PSR System2023-03-30

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K183489 — D2P2019-08-29
K190044 — VSP Orthopedics System2019-08-21

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