The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite Nailing System.
| Device ID | K111056 |
| 510k Number | K111056 |
| Device Name: | PICCOLO COMPOSITE NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CARBOFIX ORTHOPEDICS LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-05-03 |
| Summary: | summary |