INTRAMEDULLARY NAIL AND SCREWS-NEONAIL— 510(k) K141103

Substantially Equivalent

Neoortho Produtos Ortopedicos S/A

FDA 510(k) clearance K141103 for INTRAMEDULLARY NAIL AND SCREWS-NEONAIL, Substantially Equivalent on 2014-09-23. Applicant: Neoortho Produtos Ortopedicos S/A.

Clearance details

Applicant: Neoortho Produtos Ortopedicos S/A
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2014-04-29
Decision date: 2014-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.