The following data is part of a premarket notification filed by Citieffe with the FDA for Citieffe Titanium Nailing System.
| Device ID | K113387 |
| 510k Number | K113387 |
| Device Name: | CITIEFFE TITANIUM NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-03-15 |