FDA 510(k) Application Details - K223075

Device Classification Name	More FDA Info for this Device
510(K) Number	K223075
Device Name	Ogmend« Implant Enhancement System
Applicant	Woven Orthopedic Technologies 63 Center Street #3a Manchester, CT 06040 US Other 510(k) Applications for this Company
Contact	Brandon Bendes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	02/27/2023
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