FDA 510(k) Application Details - K222501

Device Classification Name	More FDA Info for this Device
510(K) Number	K222501
Device Name	Regeneten Bioinductive Implant
Applicant	Smith and Nephew Inc 150 Minuteman Road Andover, MA 01810 US Other 510(k) Applications for this Company
Contact	Jenna Horsley Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2022
Decision Date	05/11/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review