K150222 is an FDA 510(k) clearance for the X-Guide Surgical Navigation System. This device is classified as a Dental Stereotaxic Instrument (Class II - Special Controls, product code PLV).
Submitted by X-Nav Technologies, LLC (Lansdale, US). The FDA issued a Cleared decision on October 8, 2015, 251 days after receiving the submission on January 30, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120. To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous..
| 510(k) Number | K150222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2015 |
| Decision Date | October 08, 2015 |
| Days to Decision | 251 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLV - Dental Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |
| Definition | To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous. |