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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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