K240061

Substantially Equivalent

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

Applicant: Smith & Nephew, Inc.
Product code: JDS
Advisory panel: Orthopedic
Date received: 2024-01-09
Decision date: 2024-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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.