xvision Spine system— 510(k) K251639

Substantially Equivalent

Augmedics, Ltd.

FDA 510(k) clearance K251639 for xvision Spine system, Substantially Equivalent on 2025-10-03. Applicant: Augmedics, Ltd..

Clearance details

Applicant: Augmedics, Ltd.
Product code: Code SBF
Advisory panel: Neurology
Date received: 2025-05-29
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

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