OBS Anchorage Screw, Biokey Anchorage Screw— 510(k) K202278

Name: FDA 510(k) clearance K202278
Creator: U.S. Food and Drug Administration
Published: 2021-01-08

Substantially Equivalent

Bomei Co, Ltd.

FDA 510(k) clearance K202278 for OBS Anchorage Screw, Biokey Anchorage Screw, Substantially Equivalent on 2021-01-08. Applicant: Bomei Co, Ltd.. Device class: 2.

Clearance details

Applicant: Bomei Co, Ltd.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2020-08-11
Decision date: 2021-01-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

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K152297 — OBS Anchorage Screw2016-02-09

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.