NEO TITANIUM MESH, CTI-MEM— 510(k) K111761

Substantially Equivalent

Neobiotech Co., Ltd.

FDA 510(k) clearance K111761 for NEO TITANIUM MESH, CTI-MEM, Substantially Equivalent on 2012-01-10. Applicant: Neobiotech Co., Ltd..

Clearance details

Applicant: Neobiotech Co., Ltd.
Product code: Code JEY
Advisory panel: Dental
Date received: 2011-06-23
Decision date: 2012-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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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.