HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors— 510(k) K241010

Substantially Equivalent

Depuy Mitek

FDA 510(k) clearance K241010 for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors, Substantially Equivalent on 2024-09-11. Applicant: Depuy Mitek.

Clearance details

Applicant: Depuy Mitek
Product code: 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

Download summary PDF View on FDA.gov ↗

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.