Leforte MMF System
FDA 510(k) K252246 · Jeil Medical Corporation
510(k) numberK252246
Submission
- Device name
- Leforte MMF System
- Applicant
- Jeil Medical Corporation
Seoul, KR - Received
- July 18, 2025
- Decision date
- April 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Leforte MMF System cleared by the FDA?
Leforte MMF System (K252246) received a 510(k) decision of Substantially Equivalent on April 2, 2026, 258 days after the submission was received.
What is the product code of K252246?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.