FDA 510(k) Application Details - K243904

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K243904
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	CLARIANCE 18, rue Robespierre Beaurains 62217 FR Other 510(k) Applications for this Company
Contact	Quang Tran 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	12/19/2024
Decision Date	01/14/2025
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