510(k) K122123— 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED

Substantially Equivalent

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: 2012-07-18
Decision date: 2012-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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.