ATOZ Mini-Screw— 510(k) K210559

Substantially Equivalent

Mk Meditech, Inc.

FDA 510(k) clearance K210559 for ATOZ Mini-Screw, Substantially Equivalent on 2021-12-19. Applicant: Mk Meditech, Inc..

Clearance details

Applicant: Mk Meditech, Inc.
Product code: Code OAT
Advisory panel: Dental
Date received: 2021-02-25
Decision date: 2021-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.