METICULY Patient-specific titanium maxillofacial mesh implant— 510(k) K232889

Substantially Equivalent

Meticuly Co., Ltd.

FDA 510(k) clearance K232889 for METICULY Patient-specific titanium maxillofacial mesh implant, Substantially Equivalent on 2024-04-30. Applicant: Meticuly Co., Ltd..

Clearance details

Applicant: Meticuly Co., Ltd.
Product code: Code JEY
Advisory panel: Dental
Date received: 2023-09-18
Decision date: 2024-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangkok, TH

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.