# K131005: EBA2 Femoral Nailing System

- Pathway: 510(k) (Special)
- Applicant: Citieffe S.R.L.
- Decided: Jun 25, 2013 after 75 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
EBA2 Femoral Nailing System is intended for insertion into the meduillary canai of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These inciude: traumatic fractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

Source page: https://510kreport.com/device/K131005
Methodology: https://510kreport.com/methodology