FDA 510(k) Application Details - K243643

Device Classification Name	More FDA Info for this Device
510(K) Number	K243643
Device Name	restor3d Reverse Total Shoulder Arthroplasty System
Applicant	restor3d 4001 NC-54 Hwy Suite 2160 Durham, NC 27709 US Other 510(k) Applications for this Company
Contact	Brianna Prindle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	05/19/2025
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