FDA 510(k) Application Details - K243665

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K243665
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	ZheJiang Decans Medical Devices Co., Ltd. No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District Jiaxing 314031 CN Other 510(k) Applications for this Company
Contact	Haifeng Liu 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	11/27/2024
Decision Date	01/31/2025
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