FDA 510(k) Application Details - K250108

Device Classification Name	More FDA Info for this Device
510(K) Number	K250108
Device Name	OptiVuÖ Shoulder
Applicant	MR Surgical Solutions, LLC 425 Fayette Street, #617 Conshohocken, PA 19428 US Other 510(k) Applications for this Company
Contact	Brian Karpinski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2025
Decision Date	07/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review