FDA 510(k) Application Details - K122630

Device Classification Name	More FDA Info for this Device
510(K) Number	K122630
Device Name	IN:C2 SPINAL FIXATION SYSTEM
Applicant	SPINE SMITH PARTNERS L.P. 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	08/28/2012
Decision Date	12/05/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review