FDA 510(k) Application Details - DEN180065

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180065
Device Name	OGmend Implant System
Applicant	Woven Orthopedic Technologies, LLC 63 E. Center Street Manchester, CT 06040 US Other 510(k) Applications for this Company
Contact	Bob Luzzi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2018
Decision Date	05/01/2020
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review