FDA 510(k) Application Details - K222423

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K222423
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro Seongnam 13511 KR Other 510(k) Applications for this Company
Contact	Gun Tak Lee Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2022
Decision Date	03/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review