Mixed Reality Spine Navigation
FDA 510(k) clearance K242569 · decided 2025-05-16
Clearance details
- K-number
- K242569
- Device name
- Mixed Reality Spine Navigation
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2024-08-28
- Decision date
- 2025-05-16
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- SBF
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Munich, DE
- 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 |
|---|---|---|
| xvision Spine system (K261854) | Augmedics, Ltd. | 2026-07-31 |
| Knee+ (K253805) | Pixee Medical S.A.S. | 2026-04-24 |
| NextAR Hip Platform (K252847) | Medacta International S.A. | 2026-01-09 |
| xvision Spine system (K251639) | Augmedics, Ltd. | 2025-10-03 |
| SpineAR SNAP (SyncAR Spine) (K252054) | Surgical Theater, Inc. | 2025-09-29 |
| OptiVu™ Shoulder (K252530) | Mr Surgical Solutions, LLC | 2025-09-10 |
| NextAR(TM) Shoulder Platform (K251737) | Medacta International S.A. | 2025-09-04 |
| OptiVu™ Shoulder (K252170) | Mr Surgical Solutions, LLC | 2025-08-08 |
| NextAR(TM) Spine (K250477) | Medacta International S.A. | 2025-07-31 |
| OptiVu™ Shoulder (K250108) | Mr Surgical Solutions, LLC | 2025-07-09 |
| ExcelsiusXR™ (K241525) | Globus Medical, Inc. | 2025-07-08 |
| ARVIS Surgical Navigation System (K243980) | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
Recalls involving this device
No recalls on record reference this clearance.