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FDA 510(k)

METICULY Patient-specific titanium maxillofacial mesh implant

K-Number: K232889 · 2024-04-30

ApplicantMeticuly Co., Ltd.
Decision Date2024-04-30
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METICULY Patient-specific titanium maxillofacial mesh implant is a medical device manufactured by Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under approval number K232889. 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 titanium maxillofacial mesh implant?

METICULY Patient-specific titanium maxillofacial mesh implant is a medical device that received FDA 510(k) clearance on 2024-04-30. It is manufactured by Meticuly Co., Ltd.. The 510(k) number is K232889.

When was METICULY Patient-specific titanium maxillofacial mesh implant approved by the FDA?

METICULY Patient-specific titanium maxillofacial mesh implant received FDA 510(k) clearance on 2024-04-30, under approval number K232889.

What company makes METICULY Patient-specific titanium maxillofacial mesh implant?

METICULY Patient-specific titanium maxillofacial mesh implant is manufactured by Meticuly Co., Ltd..

What is the FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant?

The FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant is JEY.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Other Devices by Meticuly Co., Ltd.

K210099Meticuly Patient-Specific Titanium Mesh Implant K252958METICULY Patient-specific titanium mesh implant

Related Devices (Code: JEY)

K160363OPTIMUS CMF SYSTEMOsteonic Co., Ltd. K163579KLS Martin Individual Patient SolutionsKLS Martin L.P. K170773Stryker Universal MeshStryker K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker K170272TruMatch CMF Titanium 3D Printed Implant SystemMaterialise NV K171364MP LeFort I PlatesStryker

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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