Cadence Ankle PSI System— 510(k) K243174

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K243174 for Cadence 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

K243173 — Salto Talaris 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

More clearances from 3D Systems, Inc.

K261826 — VSP System (Titanium Palatal Splint)2026-06-03
K250711 — VSP Orthopedics System2025-12-05
K231834 — VSP PEEK Cranial Implant2024-04-04
K183489 — D2P2019-08-29
K190044 — VSP Orthopedics System2019-08-21

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