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

Substantially Equivalent

Meticuly Co., Ltd.

Clearance details

Applicant: Meticuly Co., Ltd.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2025-09-16
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangkok, TH

Adverse events under product code GXN

product code GXN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.