FDA 510(k) Application Details - K232144

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K232144
Device Name	Plate, Fixation, Bone
Applicant	Medartis AG Hochbergerstrasse 60E Basel 4057 CH Other 510(k) Applications for this Company
Contact	Claudia De Santis Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/19/2023
Decision Date	08/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review