FDA 510(k) Application Details - K223640

Device Classification Name	Cuff, Nerve   More FDA Info for this Device
510(K) Number	K223640
Device Name	Cuff, Nerve
Applicant	AxoGen Corporation 13631 Progress Blvd, Ste 400 Alachua, FL 32615-9409 US Other 510(k) Applications for this Company
Contact	Jonathan White Other 510(k) Applications for this Contact
Regulation Number	882.5275   More FDA Info for this Regulation Number
Classification Product Code	JXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2022
Decision Date	04/07/2023
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