The following data is part of a premarket notification filed by Prodigident, Inc. with the FDA for Implastation.
| Device ID | K210241 |
| 510k Number | K210241 |
| Device Name: | ImplaStation |
| Classification | System, Image Processing, Radiological |
| Applicant | Prodigident, Inc. 1350 Lake Street, Suite 1B Roselle, IL 60172 |
| Contact | Andrii Gromov |
| Correspondent | Andrii Gromov Prodigident, Inc. 1350 Lake Street, Suite 1B Roselle, IL 60172 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-12-03 |