FDA 510(k) Application Details - K173432

Device Classification Name	More FDA Info for this Device
510(K) Number	K173432
Device Name	ENZA-A Titanium ALIF
Applicant	Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087 US Other 510(k) Applications for this Company
Contact	Damian Heinz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2017
Decision Date	04/18/2018
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