xvision Spine system
FDA 510(k) K251639 · Augmedics, Ltd.
510(k) numberK251639
Submission
- Device name
- xvision Spine system
- Applicant
- Augmedics, Ltd.
Yokneam Illit, IL - Received
- May 29, 2025
- Decision date
- October 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SBF – Orthopedic Augmented Reality
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.
Other 510(k)s with product code SBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261854 | xvision Spine systemSBF · Traditional | Augmedics, Ltd. | 07/31/2026SE |
| K253805 | Knee+SBF · Traditional | Pixee Medical S.A.S. | 04/24/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | Medacta International S.A. | 01/09/2026SE |
| K252054 | SpineAR SNAP (SyncAR Spine)SBF · Traditional | Surgical Theater, Inc. | 09/29/2025SE |
| K252530 | OptiVu ShoulderSBF · Special | Mr Surgical Solutions, LLC | 09/10/2025SE |
| K251737 | NextAR(TM) Shoulder PlatformSBF · Traditional | Medacta International S.A. | 09/04/2025SE |
| K252170 | OptiVu ShoulderSBF · Special | Mr Surgical Solutions, LLC | 08/08/2025SE |
| K250477 | NextAR(TM) SpineSBF · Traditional | Medacta International S.A. | 07/31/2025SE |
| K250108 | OptiVu ShoulderSBF · Traditional | Mr Surgical Solutions, LLC | 07/09/2025SE |
| K241525 | ExcelsiusXRSBF · Traditional | Globus Medical, Inc. | 07/08/2025SE |
More from Globus Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261854 | xvision Spine systemSBF · Traditional | 07/31/2026SE |
| K250255 | xvision Spine systemSBF · Special | 03/13/2025SE |
| K241481 | xvision Spine SystemSBF · Traditional | 10/16/2024SE |
| K220905 | xvision Spine SystemSBF · Traditional | 11/17/2022SE |
| K211188 | xvision Spine system (XVS)SBF · Traditional | 07/19/2021SE |
| K190929 | xvision Spine system (XVS)SBF · Traditional | 12/20/2019SE |
Questions and answers
When was xvision Spine system cleared by the FDA?
xvision Spine system (K251639) received a 510(k) decision of Substantially Equivalent on October 3, 2025, 127 days after the submission was received.
What is the product code of K251639?
The FDA product code is SBF – Orthopedic Augmented Reality, a Class II (moderate risk) device regulated under 21 CFR 882.4560.