FDA 510(k) Application Details - K192417

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K192417
Device Name	Screw, Fixation, Bone
Applicant	Jeil Medical Corporation 702,703,704,705,706,804,805,807,812,815-ho, 55, Digital-ro 34-gil, Guro-gu Seoul 38378 KR Other 510(k) Applications for this Company
Contact	Sejin Ryu 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	09/04/2019
Decision Date	11/26/2019
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