FDA 510(k) Application Details - K230517

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K230517
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	Jarmon Medical, LLC (DBA Legends Orthopedics) 169 E Reynolds Road, Suite 203B Lexington, KY 40517 US Other 510(k) Applications for this Company
Contact	Jeremy Jarmon 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	02/27/2023
Decision Date	09/11/2023
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