FDA 510(k) Application Details - K243790

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K243790
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	DePuy Mitek 325 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	Ashley Aromando Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2024
Decision Date	02/05/2025
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