510(k) K150222 ยท PLV Dental Stereotaxic Instrument
X-Guide Surgical Navigation System
| Applicant | X-Nav Technologies, LLC, Lansdale PA, US |
| Decision | Substantially Equivalent, Oct 8, 2015 |
| Received | Jan 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2016 | X-NAV Technologies, LLC X-Guide Surgical Navigation System, X-Clip Bulk Kit
The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase Terminated |
PLV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.