510(k) K251639
K251639 is an FDA 510(k) premarket notification submitted by Augmedics, Ltd. for the device "xvision Spine system". The FDA issued a decision of Substantially Equivalent on October 3, 2025. The device falls under product code SBF (Orthopedic Augmented Reality), a Class II device regulated under 21 CFR 882.4560. Augmedics, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2025
- Date Received
- May 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Augmented Reality
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
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.