EBA2 FEMORAL NAILING SYSTEM— 510(k) K131005

Substantially Equivalent

Citieffe S.R.L.

FDA 510(k) clearance K131005 for EBA2 FEMORAL NAILING SYSTEM, Substantially Equivalent on 2013-06-25. Applicant: Citieffe S.R.L..

Clearance details

Applicant: Citieffe S.R.L.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2013-04-11
Decision date: 2013-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.