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FDA 510(k) Application Details - K202750
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K202750
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Pixee Medical
18 rue Alain Savary
Besancon 25000 FR
Other 510(k) Applications for this Company
Contact
Lucie Pecheur
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2020
Decision Date
04/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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