SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX— 510(k) K113733

Substantially Equivalent

Neoortho Produtos Ortopedicos S/A

FDA 510(k) clearance K113733 for SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX, Substantially Equivalent on 2012-03-23. Applicant: Neoortho Produtos Ortopedicos S/A.

Clearance details

Applicant: Neoortho Produtos Ortopedicos S/A
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2011-12-19
Decision date: 2012-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.