K043248

Substantially Equivalent

TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS

Applicant: Arthrex, Inc.
Product code: HTN
Advisory panel: Orthopedic
Date received: 2004-11-23
Decision date: 2005-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.