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510(k) K220905

xvision Spine System by Augmedics, Ltd. — Product Code SBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2022
Date Received
March 28, 2022
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 user’s field of view.

Other clearances by Augmedics, Ltd.

  • K251639 — xvision Spine system (October 3, 2025)
  • K250255 — xvision Spine system (March 13, 2025)
  • K241481 — xvision Spine System (October 16, 2024)
  • K211188 — xvision Spine system (XVS) (July 19, 2021)
  • K190929 — xvision Spine system (XVS) (December 20, 2019)

Other clearances for product code SBF

  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K251639 — xvision Spine system (October 3, 2025)
  • K252054 — SpineAR SNAP (SyncAR Spine) (September 29, 2025)
  • K252530 — OptiVu™ Shoulder (September 10, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K252170 — OptiVu™ Shoulder (August 8, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)
  • K250108 — OptiVu™ Shoulder (July 9, 2025)
  • K241525 — ExcelsiusXR™ (July 8, 2025)
  • K242569 — Mixed Reality Spine Navigation (May 16, 2025)