The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Piccolo Composite Plate System.
| Device ID | K143496 |
| 510k Number | K143496 |
| Device Name: | Piccolo Composite Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 46724 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 46724 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-09 |
| Decision Date | 2015-05-29 |