FDA 510(k) Application Details - K241470

Device Classification Name	More FDA Info for this Device
510(K) Number	K241470
Device Name	CORE Shoulder System
Applicant	LinkBio Corp. 69 King Street Dover, NJ 07801 US Other 510(k) Applications for this Company
Contact	Deniz Kortan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2024
Decision Date	02/20/2025
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