ORTHOFIX SCREW— 510(k) K113650

Substantially Equivalent

Bonafix Surgical and Dental Implants, LLC

FDA 510(k) clearance K113650 for ORTHOFIX SCREW, Substantially Equivalent on 2012-10-03. Applicant: Bonafix Surgical and Dental Implants, LLC.

Clearance details

Applicant: Bonafix Surgical and Dental Implants, LLC
Product code: Code OAT
Advisory panel: Dental
Date received: 2011-12-12
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 118 W Prive Cr., FL, US

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.