FDA 510(k) Application Details - K242869

Device Classification Name	More FDA Info for this Device
510(K) Number	K242869
Device Name	prodisc« L Instruments
Applicant	Centinel Spine LLC 900 Airport Road, Suite 3B West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Jessica Staub Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2024
Decision Date	12/17/2024
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