FDA.report

510(k) K241525

Device
ExcelsiusXR™
Applicant
Globus Medical, Inc.
510(k) number
K241525
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-08
Date received
2024-05-30
Regulation
882.4560
Classification name
Orthopedic Augmented Reality
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jennifer Antonacci
Address
Valley Forge Business Center 2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code SBF

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K253805Knee+Pixee Medical S.A.S.2026-04-24
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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
K242569Mixed Reality Spine NavigationBrainlab AG2025-05-16
K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited2025-03-21
K243975Knee+Pixee Medical2025-03-20
K250255xvision Spine systemAugmedics, Ltd.2025-03-13
K243950ARVIS® ShoulderKico Knee Innovation Company Pty, Ltd.2025-01-13
K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.2024-12-24