The following data is part of a premarket notification filed by Citieffe S.r.l. with the FDA for Eba2 Femoral Nailing System.
| Device ID | K131005 |
| 510k Number | K131005 |
| Device Name: | EBA2 FEMORAL NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CITIEFFE S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Contact | Claude Berthion |
| Correspondent | Claude Berthion CITIEFFE S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-11 |
| Decision Date | 2013-06-25 |