OsteoMed IMF Screw— 510(k) K151195

Substantially Equivalent

Osteomed

FDA 510(k) clearance K151195 for OsteoMed IMF Screw, Substantially Equivalent on 2015-09-21. Applicant: Osteomed.

Clearance details

Applicant: Osteomed
Product code: Code DZL
Advisory panel: Dental
Date received: 2015-05-04
Decision date: 2015-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, 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.