FDA 510(k) Application Details - K191424

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K191424
Device Name	Screw, Fixation, Bone
Applicant	Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes 44 100 FR Other 510(k) Applications for this Company
Contact	Anne-Cecile Grandremy 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	05/29/2019
Decision Date	08/28/2019
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