FDA 510(k) Application Details - K240592

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K240592
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Spinal Simplicity LLC 6363 College Blvd Ste 320 Overland Park, KS 66211 US Other 510(k) Applications for this Company
Contact	Adam Rogers Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2024
Decision Date	05/24/2024
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