The following data is part of a premarket notification filed by Dio Medical Corporation with the FDA for Faset Fixation System.
| Device ID | K222515 |
| 510k Number | K222515 |
| Device Name: | FaSet Fixation System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, PA 19403 |
| Contact | Milan George |
| Correspondent | Milan George Dio Medical Corporation 2100 Campus Lane, Suite 100 East Norriton, PA 19403 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-19 |
| Decision Date | 2022-10-05 |