MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture— 510(k) K160854

Substantially Equivalent

Biomet Manafacturing Corp.

FDA 510(k) clearance K160854 for MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture, Substantially Equivalent on 2016-12-19. Applicant: Biomet Manafacturing Corp..

Clearance details

Applicant: Biomet Manafacturing Corp.
Product code: Code GAT
Advisory panel: General, Plastic Surgery
Date received: 2016-03-28
Decision date: 2016-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

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.