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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2025 | K252376 | Yomi S Robotic System Neocis, Inc. | PLV |
| Oct 10, 2025 | K251835 | Yomi Robotic System Neocis, Inc. | PLV |
| Jul 25, 2024 | K233563 | Navident Claronav, Inc., CA | PLV |
| Aug 14, 2023 | K231018 | Yomi Robotic System Neocis, Inc. | PLV |
| Jun 27, 2022 | K210947 | Navident Claronav, Inc., CA | PLV |
| Jun 14, 2022 | K211466 | Yomi Robotic System with YomiPlan Go Neocis, Inc. | PLV |
| Feb 22, 2022 | K213392 | INLIANT Surgical Navigation System Navigate Surgical Technologies, Inc., CA | PLV |
| Dec 22, 2021 | K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 Neocis, Inc. | PLV |
| Jul 28, 2021 | K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array Neocis, Inc. | PLV |
| Dec 15, 2020 | K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) Neocis, Inc. | PLV |
| Dec 4, 2020 | K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 Neocis, Inc. | PLV |
| Oct 19, 2020 | K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) Neocis, Inc. | PLV |
| Jul 28, 2020 | K200805 | Neocis Guidance System (NGS) with Patient Splints Neocis, Inc. | PLV |
| May 21, 2020 | K200662 | X-Guide® Surgical Navigation System X-Nav Technologies, LLC | PLV |
| May 8, 2020 | K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) Neocis, Inc. | PLV |
| Feb 3, 2020 | K192579 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | PLV |
| Oct 2, 2019 | K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs Neocis, Inc. | PLV |
| Sep 11, 2019 | K191605 | Neocis Guidance System (NGS) Neocis, Inc. | PLV |
| Dec 21, 2018 | K182776 | Neocis Guidance System Neocis, Inc. | PLV |
| Feb 22, 2018 | K173402 | Neocis Guidance System (NGS) with Chairside Splint Neocis, Inc. | PLV |
| Dec 22, 2016 | K161399 | Neocis Guidance System Neocis, Inc. | PLV |
| Sep 8, 2016 | K161406 | Navident Claronav, Inc., CA | PLV |
| Oct 8, 2015 | K150222 | X-Guide Surgical Navigation System X-Nav Technologies, LLC | PLV |
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