FDA 510(k) Application Details - K250760

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K250760
Device Name	Bone Cement
Applicant	OsteoRemedies, LLC 6800 Poplar Ave Suite 120 Memphis, TN 38138 US Other 510(k) Applications for this Company
Contact	Rachel Kennedy Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	LOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2025
Decision Date	04/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review