xvision Spine system— 510(k) K261854
Substantially EquivalentAugmedics, Ltd.
FDA 510(k) clearance K261854 for xvision Spine system, Substantially Equivalent on 2026-07-31. Applicant: Augmedics, Ltd.. Device class: 2.
Summary
Augmedics' xvision Spine system is filed under SBF, orthopedic augmented reality. The record doesn't describe its components or outputs.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Augmedics filed from Yokneam Illit, Israel. Review took 58 calendar days (June 3 to July 31, 2026).
Clearance details
- Applicant
- Augmedics, Ltd.
- Product code
- Product code SBF
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yokneam Illit, IL
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