FDA 510(k) Application Details - K190546

Device Classification Name	More FDA Info for this Device
510(K) Number	K190546
Device Name	NEXXT MATRIXX Stand Alone Cervical System
Applicant	Nexxt Spine LLC 14425 Bergen Blvd, Suite B Noblesville, IN 46060 US Other 510(k) Applications for this Company
Contact	Andy Elsbury Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2019
Decision Date	05/31/2019
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