FDA 510(k) Application Details - K170313

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K170313
Device Name	Plate, Fixation, Bone
Applicant	Jeil Medical Corporation #702, Kolon Science Valley 2nd 55, Digital-ro 34, Guro-gu Seoul 152-728 KR Other 510(k) Applications for this Company
Contact	Sejin RYU 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	02/01/2017
Decision Date	07/27/2017
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