MySpine WebPlanner
FDA 510(k) K243697 · Medacta International S.A.
510(k) numberK243697
Submission
- Device name
- MySpine WebPlanner
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- November 29, 2024
- Decision date
- April 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MySpine WebPlanner cleared by the FDA?
MySpine WebPlanner (K243697) received a 510(k) decision of Substantially Equivalent on April 23, 2025, 145 days after the submission was received.
What is the product code of K243697?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.