The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite Nailing System.
| Device ID | K173652 |
| 510k Number | K173652 |
| Device Name: | Piccolo Composite Nailing System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-28 |
| Decision Date | 2017-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110201555 | K173652 | 000 |
| 07290110201548 | K173652 | 000 |
| 07290110201531 | K173652 | 000 |
| 07290110201524 | K173652 | 000 |
| 07290110201517 | K173652 | 000 |
| 07290110201500 | K173652 | 000 |
| 07290110201494 | K173652 | 000 |