The following data is part of a premarket notification filed by Carbofix Orthopedics Ltd. with the FDA for Carboclear X Pedicle Screw System, Carboclear X Navigated Instruments.
| Device ID | K210716 |
| 510k Number | K210716 |
| Device Name: | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Contact | Hila Wachsler-avrahami |
| Correspondent | Hila Wachsler-avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya, IL 4672411 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-10 |
| Decision Date | 2021-04-06 |
| Summary: | summary |