ALPHA BIO BONE FIXATION SCREW SYSTEM— 510(k) K063769

Substantially Equivalent

Alpha-Bio Tec , Ltd.

FDA 510(k) clearance K063769 for ALPHA BIO BONE FIXATION SCREW SYSTEM, Substantially Equivalent on 2007-03-30. Applicant: Alpha-Bio Tec , Ltd..

Clearance details

Applicant: Alpha-Bio Tec , Ltd.
Product code: Code DZL
Advisory panel: Dental
Date received: 2006-12-20
Decision date: 2007-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.