MEMFIX SCREWS— 510(k) K910427

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K910427 for MEMFIX SCREWS, Substantially Equivalent on 1991-09-30. Applicant: W. L. Gore & Associates, Inc..

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code DZL
Advisory panel: Dental
Date received: 1991-02-01
Decision date: 1991-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.