X-Guide® Surgical Navigation System
FDA 510(k) clearance K211701 · decided 2022-02-01
Clearance details
- K-number
- K211701
- Device name
- X-Guide® Surgical Navigation System
- Applicant
- X-Nav Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-06-03
- Decision date
- 2022-02-01
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- QRY
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lansdale, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| X-Guide Surgical Navigation System (K232148) | X-Nav Technologies, LLC | 2024-02-21 |
| Yomi Robotic System (K222750) | Neocis, Inc. | 2022-12-08 |
| Yomi Robotic System (K222049) | Neocis, Inc. | 2022-11-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or per recall (Z-0222-2023) | X-NAV Technologies, LLC | 2022-11-10 |