FDA 510(k) Application Details - K180087

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K180087
Device Name	Pin, Fixation, Smooth
Applicant	A.M. Surgical, Inc 222 Middle Country Road Suite 202 Smithtown, NY 11787 US Other 510(k) Applications for this Company
Contact	Gavriel Feuer Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2018
Decision Date	05/18/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review