FDA 510(k) Application Details - K133827

Device Classification Name	More FDA Info for this Device
510(K) Number	K133827
Device Name	A-LINK Z
Applicant	OSTEO VASIVE LLC 12264 EL CAMINO REAL SUITE 400 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	KEVIN A THOMAS 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	12/17/2013
Decision Date	11/17/2014
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