The following data is part of a premarket notification filed by Sonex Health, Inc. with the FDA for Sx-one Microknife.
| Device ID | K192873 |
| 510k Number | K192873 |
| Device Name: | SX-One MicroKnife |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | Sonex Health, Inc. 11 1st Ave SW Rochester, MN 55902 |
| Contact | Aaron Keenan |
| Correspondent | Keri Ng Keri Ng Consulting 11 1st Ave SW Rochester, MN 55902 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-08 |
| Decision Date | 2019-12-20 |