K140127

Substantially Equivalent

FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

Applicant: Pontis Orthopaedics, LLC
Product code: GAQ
Advisory panel: General, Plastic Surgery
Date received: 2014-01-16
Decision date: 2014-05-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, CA, US

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.