Knee+

Orthopedic Stereotaxic Instrument

Pixee Medical

The following data is part of a premarket notification filed by Pixee Medical with the FDA for Knee+.

Pre-market Notification Details

Device IDK202750
510k NumberK202750
Device Name:Knee+
ClassificationOrthopedic Stereotaxic Instrument
Applicant Pixee Medical 18 Rue Alain Savary Besancon,  FR 25000
ContactLucie Pecheur
CorrespondentLucie Pecheur
Pixee Medical 18 Rue Alain Savary Besancon,  FR 25000
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-04-21

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