K241010

Substantially Equivalent

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

Applicant: Depuy Mitek
Product code: MAI
Advisory panel: Orthopedic
Date received: 2024-04-12
Decision date: 2024-09-11
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.