510(k) K131974— HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

Clearance details

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2013-06-28
Decision date: 2013-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.