SYNTHES (USA) TITANIUM WIRE— 510(k) K041333

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K041333 for SYNTHES (USA) TITANIUM WIRE, Substantially Equivalent on 2004-08-27. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 2004-05-19
Decision date: 2004-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.