MySpine WebPlanner— 510(k) K243697

Name: FDA 510(k) clearance K243697
Creator: U.S. Food and Drug Administration
Published: 2025-04-23

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K243697 for MySpine WebPlanner, Substantially Equivalent on 2025-04-23. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-11-29
Decision date: 2025-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

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K253940 — M.U.S.T. Pedicle Screw System - Extension2026-04-28
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
K250644 — MSS - Monobloc stem2026-02-03

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.