FDA 510(k) Application Details - DEN220015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220015
Device Name	Orthobond Mariner Pedicle Screw System
Applicant	Orthobond Coporation 1 Deerpark Dr, Ste A Monmouth, NJ 08852 US Other 510(k) Applications for this Company
Contact	David Nichols Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2022
Decision Date	04/05/2024
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