METICULY Patient-specific titanium mesh implant— 510(k) K252958

Clearance details

Applicant

Meticuly Co., Ltd.

Product code

Code GXN

Device class

Class 2

Regulation

21 CFR 882.5330

Advisory panel

Neurology

Date received

2025-09-16

Decision date

2026-01-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bangkok, TH

• K260709 — ClearFit Ti Ring 14mm (171750) +4 more2026-06-25
• K253116 — 3D MAC Titanium Cranial Plate (TCP) System2026-06-18
• K252251 — EASYMADE-TI2026-04-09
• K243715 — Synthes Patient Specific Implants2025-11-12
• K252573 — KLS Martin Cranial Implants - MR Conditional +6 more2025-11-10

• K253206 — METICULY Patient-specific CMF solution2026-07-25
• K232889 — METICULY Patient-specific titanium maxillofacial mesh implant2024-04-30
• K210099 — Meticuly Patient-Specific Titanium Mesh Implant2021-12-21

Injury

208

Total

208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →