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FDA 510(k)

METICULY Patient-specific CMF solution

K-Number: K253206 · 2026-07-25

ApplicantMeticuly Co., Ltd.
Decision Date2026-07-25
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METICULY Patient-specific CMF solution is the device name listed in this FDA 510(k) record. The listed applicant is Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2026-07-25 under 510(k) number K253206. 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 METICULY Patient-specific CMF solution?

METICULY Patient-specific CMF solution is a medical device that received FDA 510(k) clearance on 2026-07-25. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K253206.

When did METICULY Patient-specific CMF solution receive FDA 510(k) clearance?

METICULY Patient-specific CMF solution received FDA 510(k) clearance on 2026-07-25, under 510(k) number K253206.

Who is the listed applicant for METICULY Patient-specific CMF solution?

The FDA 510(k) record lists Meticuly Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METICULY Patient-specific CMF solution?

The FDA product code for METICULY Patient-specific CMF solution is JEY.

Other records listing Meticuly Co., Ltd. as applicant

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.

K252958METICULY Patient-specific titanium mesh implantK232889METICULY Patient-specific titanium maxillofacial mesh implantK210099Meticuly Patient-Specific Titanium Mesh Implant

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.

K252246Leforte MMF SystemJeil Medical CorporationK253373Southern 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

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

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