510(k) K161399 ยท PLV Dental Stereotaxic Instrument
Neocis Guidance System
| Applicant | Neocis, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | May 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Neocis Inc. Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and th Terminated |
PLV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.