FDA 510(k) Application Details - K230123

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K230123
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Maruho Medical 3005 Chastain Meadows Pkwy, suite 300 Marietta, GA 30066 US Other 510(k) Applications for this Company
Contact	Yannick Spenninck 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	01/17/2023
Decision Date	05/03/2023
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