OrthoNext Platform System— 510(k) K202519

Name: FDA 510(k) clearance K202519
Creator: U.S. Food and Drug Administration
Published: 2020-10-27

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K202519 for OrthoNext Platform System, Substantially Equivalent on 2020-10-27. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-09-01
Decision date: 2020-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bussolengo, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

More clearances from Orthofix Srl

view all

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
K242270 — OrthoNext Platform System2024-12-19
K242861 — TrueLok Elevate2024-12-03

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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