K043298

Substantially Equivalent

BLUE ORTHOCORD SUTURE

Applicant: Depuy Mitek
Product code: NEW
Advisory panel: General, Plastic Surgery
Date received: 2004-11-30
Decision date: 2004-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwood, MA, US

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

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.