FDA 510(k) Application Details - K212545

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K212545
Device Name	Plate, Fixation, Bone
Applicant	Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes 44 100 FR Other 510(k) Applications for this Company
Contact	JD Webb 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	08/12/2021
Decision Date	02/11/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review