TRIGEN INTERTAN 10S Nail System— 510(k) K241804

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K241804 for TRIGEN INTERTAN 10S Nail System, Substantially Equivalent on 2024-08-22. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 2024-06-21
Decision date: 2024-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.