FDA 510(k) Application Details - K223468

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K223468
Device Name	Screw, Fixation, Bone
Applicant	Novastep 2, allΘe Jacques Frimot Rennes 350000 FR Other 510(k) Applications for this Company
Contact	Gilles Audic Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2022
Decision Date	08/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review