OrthoNext Platform System— 510(k) K242270

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K242270 for OrthoNext Platform System, Substantially Equivalent on 2024-12-19. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-08-01
Decision date: 2024-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bussolengo (Vr), IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Orthofix Srl

K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM2026-05-19
K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA2026-05-08
K250112 — FitboneTM Trochanteric2025-04-10
K242861 — TrueLok Elevate2024-12-03
K233867 — Fitbone Trochanteric2024-06-18

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