FDA 510(k) Application Details - K243375

Device Classification Name	More FDA Info for this Device
510(K) Number	K243375
Device Name	Ruthless Spine RJB
Applicant	Ruthless, LLC dba Ruthless Spine 1438 Arrow Hwy Ste F Irwindale, CA 91706 US Other 510(k) Applications for this Company
Contact	Renita Howard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2024
Decision Date	11/29/2024
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