FDA 510(k) Applications for Medical Device Product Code "SBF"

FDA 510(k) Number Applicant Device Name Decision Date
K241481 Augmedics Ltd. xvision Spine System 10/16/2024
K250255 Augmedics Ltd. xvision Spine system 03/13/2025
K242569 Brainlab AG Mixed Reality Spine Navigation 05/16/2025
K241525 Globus Medical, Inc. ExcelsiusXRÖ 07/08/2025
K243980 Kico Knee Innovation Company Pty Limited ARVIS Surgical Navigation System 03/21/2025
K243950 Kico Knee Innovation Company Pty Ltd ARVIS« Shoulder 01/13/2025
K250108 MR Surgical Solutions, LLC OptiVuÖ Shoulder 07/09/2025
K241870 OnPoint Surgical, Inc. OnPoint Augmented Reality Spine System 08/19/2024
K243975 Pixee Medical Knee+ 03/20/2025
K243623 Surgical Theater, Inc. SpineAR SNAP (SyncAR Spine) 12/24/2024
K242271 Taiwan Main Orthopaedic Biotechnology Co., Ltd. Caduceus S 10/30/2024


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