FDA.report

510(k) K233899

Device
Knee+
Applicant
Pixee Medical
510(k) number
K233899
Product code
SBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-08
Date received
2023-12-11
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
Lucie Pecheur
Address
18 Rue Alain Savary Besançon FR 25000 25000

FDA Registration Numbers

Source Documents

510(k) summary PDF

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