510(k) K232148 ยท QRY Dental Navigation System
X-Guide Surgical Navigation System
| Applicant | X-Nav Technologies, LLC, Lansdale PA, US |
| Decision | Substantially Equivalent, Feb 21, 2024 |
| Received | Jul 19, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232148
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | X-NAV Technologies, LLC X-Guide Handpiece Adaptor Sleeve 1, Model P010701 Open, Classified |
QRY | None listed |
| Mar 29, 2024 | X-NAV Technologies, LLC X-Guide Handpiece Adaptor Sleeve 3, Model P010727 Open, Classified |
QRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.