510(k) K173402 ยท PLV Dental Stereotaxic Instrument
Neocis Guidance System (NGS) with Chairside Splint
| Applicant | Neocis, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 22, 2018 |
| Received | Oct 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2020 | Neocis, Inc. DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) Terminated |
PLV | None listed |
| May 14, 2020 | Neocis Inc. DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas Terminated |
PLV | None listed |
| May 14, 2020 | Neocis Inc. DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phas Terminated |
PLV | None listed |
| May 14, 2020 | Neocis Inc. DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phase Terminated |
PLV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.