RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM— 510(k) K130814

Substantially Equivalent

Depuy Mitek, A Johnson & Johnson Company

FDA 510(k) clearance K130814 for RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM, Substantially Equivalent on 2013-08-01. Applicant: Depuy Mitek, A Johnson & Johnson Company.

Clearance details

Applicant: Depuy Mitek, A Johnson & Johnson Company
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2013-03-25
Decision date: 2013-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
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.