FDA 510(k) Application Details - K180249

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K180249
Device Name	Plate, Bone
Applicant	Matrix Surgical Holdings, LLC/Matrix Surgical USA 4025 Welcome All Road Suite 120 Atlanta, GA 30349 US Other 510(k) Applications for this Company
Contact	John O'Shaughnessy Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2018
Decision Date	10/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review