FDA 510(k) Application Details - K141537

Device Classification Name	More FDA Info for this Device
510(K) Number	K141537
Device Name	IN:C2 SPINAL FIXATION SYSTME
Applicant	SPINESMITH HOLDINGS, LLC 93 RED RIVER AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	CLIFTON (CHRIS) NAIVAR 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	06/10/2014
Decision Date	11/25/2014
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