HEALIX KNOTLESS ANCHOR— 510(k) K113534

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

FDA 510(k) clearance K113534 for HEALIX KNOTLESS ANCHOR, Substantially Equivalent on 2011-12-20. Applicant: Depuy Mitek, A Johnson & Johnson Company.

Clearance details

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2011-11-30
Decision date: 2011-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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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.