FDA.report

510(k) K230789

Device
Knee+
Applicant
Pixee Medical
510(k) number
K230789
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-21
Date received
2023-03-22
Regulation
882.4560
Classification name
Orthopedic Augmented Reality
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Lucie Pécheur
Address
14 Rue Alain Savary Besancon FR 25000 25000

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code SBF

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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