Cleared Traditional

MySpine WebPlanner

K243697 · Medacta International S.A. · Radiology
Apr 2025
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K243697 is an FDA 510(k) clearance for the MySpine WebPlanner, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on April 23, 2025, 145 days after receiving the submission on November 29, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243697 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date April 23, 2025
Days to Decision 145 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050