FEMORAL INTRAFIX SCREW AND SHEATH— 510(k) K063577

Substantially Equivalent

Johnson & Johnson Company

FDA 510(k) clearance K063577 for FEMORAL INTRAFIX SCREW AND SHEATH, Substantially Equivalent on 2007-01-25. Applicant: Johnson & Johnson Company.

Clearance details

Applicant: Johnson & Johnson Company
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2006-11-30
Decision date: 2007-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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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.