510(k) K192873 ยท LXH Orthopedic Manual Surgical Instrument
SX-One MicroKnife
| Applicant | Sonex Health, Inc., Rochester MN, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Oct 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2022 | SONEX HEALTH LLC SX-One MicroKnife Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.