FDA 510(k) Application Details - K230211

Device Classification Name	More FDA Info for this Device
510(K) Number	K230211
Device Name	CranioXpand
Applicant	KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 US Other 510(k) Applications for this Company
Contact	Melissa Bachorski Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2023
Decision Date	11/21/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review