FDA 510(k) Application Details - K123497

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K123497
Device Name	System, Facet Screw Spinal Device
Applicant	FACET-LINK, INC. 1835 MARKET ST. 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2012
Decision Date	02/28/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review