HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)— 510(k) K131683

Substantially Equivalent

Depuy Mitek, Inc., A Johnson and Johnson Company

FDA 510(k) clearance K131683 for HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM), Substantially Equivalent on 2013-06-27. Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company.

Clearance details

Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2013-06-10
Decision date: 2013-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.