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FDA 510(k)

Leforte MMF System

K-Number: K252246 · 2026-04-02

ApplicantJeil Medical Corporation
Decision Date2026-04-02
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Leforte MMF System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252246. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leforte MMF System?

Leforte MMF System is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Jeil Medical Corporation. The 510(k) number is K252246.

When did Leforte MMF System receive FDA 510(k) clearance?

Leforte MMF System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252246.

Who is the listed applicant for Leforte MMF System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leforte MMF System?

The FDA product code for Leforte MMF System is JEY.

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Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KGK233874tmCMF SolutionTechmah Cmf

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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