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FDA 510(k)

METICULY Patient-specific titanium mesh implant

K-Number: K252958 · 2026-01-14

ApplicantMeticuly Co., Ltd.
Decision Date2026-01-14
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

METICULY Patient-specific titanium mesh implant 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 2026-01-14 under 510(k) number K252958. 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 2026-01-14. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K252958.

When did METICULY Patient-specific titanium mesh implant receive FDA 510(k) clearance?

METICULY Patient-specific titanium mesh implant received FDA 510(k) clearance on 2026-01-14, under 510(k) number K252958.

Who is the listed applicant for METICULY Patient-specific titanium mesh implant?

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 titanium mesh implant?

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

Related Clinical Trials

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.

NCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT07698678Evaluation of Using Patient Specific Ultra-High Molecular Weight Polyethylene Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation A Randomized Control TrialACTIVE_NOT_RECRUITINGNCT07520903Titanium-Reinforced PTFE Membranes for Bone AugmentationCOMPLETED

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.

K253206METICULY Patient-specific CMF solutionK232889METICULY Patient-specific titanium maxillofacial mesh implantK210099Meticuly Patient-Specific Titanium Mesh Implant

Related Devices (Code: GXN)

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.K240567CustomizedBone ServiceFin-Ceramica Faenza S.P.A.

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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