Dental Stereotaxic Instrument
Regulation 872.4120
0510(k)s in 12 months (23 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in PLV
| Company | 510(k)s | Recalls |
|---|---|---|
| Neocis, Inc. | 16 | 5 |
| X-Nav Technologies, LLC | 3 | 1 |
| Claronav, Inc. | 3 | 0 |
| Navigate Surgical Technologies, Inc. | 1 | 0 |
| 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 | K173402 |
| 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 | K173402 |
| 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 | K173402 |
| 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 | K173402 |
| 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 | K161399 |
| 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 | K150222 |
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