The following data is part of a premarket notification filed by X-nav Technologies, Llc with the FDA for X-guide Surgical Navigation System.
| Device ID | K192579 |
| 510k Number | K192579 |
| Device Name: | X-Guide Surgical Navigation System |
| Classification | Dental Stereotaxic Instrument |
| Applicant | X-Nav Technologies, LLC 1555 Bustard Road, Suite 75 Lansdale, PA 19446 |
| Contact | Fred Cowdery |
| Correspondent | Fred Cowdery X-Nav Technologies, LLC 1555 Bustard Road, Suite 75 Lansdale, PA 19446 |
| Product Code | PLV |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2020-02-03 |