Huvex Interspinous Fusion System— 510(k) K223790

Name: FDA 510(k) clearance K223790
Creator: U.S. Food and Drug Administration
Published: 2023-03-09

Substantially Equivalent

Dio Medical Corp.

FDA 510(k) clearance K223790 for Huvex Interspinous Fusion System, Substantially Equivalent on 2023-03-09. Applicant: Dio Medical Corp.. Device class: 2.

Clearance details

Applicant: Dio Medical Corp.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2022-12-19
Decision date: 2023-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Norriton, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PEK

view all

K253250 — Minuteman® G6 MIS Fusion Plate2025-12-01
K234051 — Minuteman G5 MIS Fusion Plate +3 more2024-01-18
K233527 — Minuteman G5 MIS Fusion Plate +3 more2023-11-29
K232484 — KeyLift Expandable Interlaminar Stabilization System2023-10-19
K231807 — primaLOK SP Interspinous Fusion System2023-08-15

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