FDA 510(k) Application Details - K231322

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K231322
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Osteonic Co., Ltd. 1206Ho, 38, Digital-ro, 29-gil, Guro-gu Seoul 08381 KR Other 510(k) Applications for this Company
Contact	Da Kyung Ham 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	05/08/2023
Decision Date	06/07/2023
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