FDA.report

510(k) K253805

Device
Knee+
Applicant
Pixee Medical S.A.S.
510(k) number
K253805
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2025-11-28
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
François Beaumont
Address
18 Rue Alain Savary Besançon FR 25000 25000

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code SBF

510(k)DeviceApplicantDecision date
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
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