FDA 510(k) Application Details - K163327

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K163327
Device Name	Pin, Fixation, Smooth
Applicant	PRECIFIT MEDICAL LTD 951 AVIATION PKWY STE 100 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	ZHEN YU(ERIC) WU 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	11/28/2016
Decision Date	05/08/2017
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