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FDA 510(k)

Meticuly Patient-Specific Titanium Mesh Implant

K-Number: K210099 · 2021-12-21

ApplicantMeticuly Co., Ltd.
Decision Date2021-12-21
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Meticuly Patient-Specific Titanium Mesh Implant is a medical device manufactured by Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2021-12-21 under approval number K210099. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Meticuly Patient-Specific Titanium Mesh Implant?

Meticuly Patient-Specific Titanium Mesh Implant is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Meticuly Co., Ltd.. The 510(k) number is K210099.

When was Meticuly Patient-Specific Titanium Mesh Implant approved by the FDA?

Meticuly Patient-Specific Titanium Mesh Implant received FDA 510(k) clearance on 2021-12-21, under approval number K210099.

What company makes Meticuly Patient-Specific Titanium Mesh Implant?

Meticuly Patient-Specific Titanium Mesh Implant is manufactured by Meticuly Co., Ltd..

What is the FDA product code for Meticuly Patient-Specific Titanium Mesh Implant?

The FDA product code for Meticuly Patient-Specific Titanium Mesh Implant is GXN.

Related Clinical Trials

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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.

K232889METICULY Patient-specific titanium maxillofacial mesh implant K252958METICULY Patient-specific titanium mesh implant

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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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