X-Guide® Surgical Navigation System
Dental Stereotaxic Instrument
X-Nav Technologies,LLC.
The following data is part of a premarket notification filed by X-nav Technologies,llc. with the FDA for X-guide® Surgical Navigation System.
Pre-market Notification Details
| Device ID | K200662 |
| 510k Number | K200662 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-13 |
| Decision Date | 2020-05-21 |
Trademark Results [X-Guide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-GUIDE 85925057 4896013 Live/Registered |
X-Nav Technologies, LLC 2013-05-07 |
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