510(k) K200662
- Device
- X-Guide® Surgical Navigation System
- Applicant
- X-Nav Technologies,LLC.
- 510(k) number
- K200662
- Product code
- PLV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-05-21
- Date received
- 2020-03-13
- Regulation
- 872.4120
- Classification name
- Dental Stereotaxic Instrument
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Fred Cowdery
- Address
- 1555 Bustard Rd. Suite 75 Lansdale PA US 19446 19446
FDA Registration Numbers#
- 3011764595
- 3021736516
- 3014552222
- 3011874573
- 3006540014
- 3012787974
Source Documents#
Other 510(k) Records For Product Code PLV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252376 | Yomi S Robotic System | Neocis, Inc. | 2025-10-28 |
| K251835 | Yomi Robotic System | Neocis, Inc. | 2025-10-10 |
| K233563 | Navident | Claronav, Inc. | 2024-07-25 |
| K231018 | Yomi Robotic System | Neocis, Inc. | 2023-08-14 |
| K210947 | Navident | Claronav, Inc. | 2022-06-27 |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | 2022-06-14 |
| K213392 | INLIANT Surgical Navigation System | Navigate Surgical Technologies, Inc. | 2022-02-22 |
| K210711 | Neocis Guidance System (NGS) with Yomi Plan v2.0.1 | Neocis, Inc. | 2021-12-22 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | 2021-07-28 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | 2020-12-15 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | 2020-12-04 |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | 2020-10-19 |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | 2020-07-28 |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | 2020-05-08 |
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2020-02-03 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases