FDA.reportPublic FDA data

510(k) K250255

Device
xvision Spine system
Applicant
Augmedics, Ltd.
510(k) number
K250255
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-13
Date received
2025-01-28
Regulation
882.4560
Classification name
Orthopedic Augmented Reality
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tami Harel
Address
2 Ha-Otsma St. Yokneam Illit IL 2069205 2069205

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253805Knee+Pixee Medical S.A.S.2026-04-24
K252847NextAR Hip PlatformMedacta International S.A.2026-01-09
K251639xvision Spine systemAugmedics, Ltd.2025-10-03
K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.2025-09-29
K252530OptiVu™ ShoulderMr Surgical Solutions, LLC2025-09-10
K251737NextAR(TM) Shoulder PlatformMedacta International S.A.2025-09-04
K252170OptiVu™ ShoulderMr Surgical Solutions, LLC2025-08-08
K250477NextAR(TM) SpineMedacta International S.A.2025-07-31
K250108OptiVu™ ShoulderMr Surgical Solutions, LLC2025-07-09
K241525ExcelsiusXR™Globus Medical, Inc.2025-07-08
K242569Mixed Reality Spine NavigationBrainlab AG2025-05-16
K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited2025-03-21
K243975Knee+Pixee Medical2025-03-20
K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.2025-01-13
K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.2024-12-24