The following data is part of a premarket notification filed by Carbofix Orthopedics, Ltd. with the FDA for Piccolo Composite Proximal Tibia Plate System.
| Device ID | K201917 |
| 510k Number | K201917 |
| Device Name: | Piccolo Composite Proximal Tibia Plate System |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2020-10-08 |