FDA 510(k) Application Details - K140046

Device Classification Name	More FDA Info for this Device
510(K) Number	K140046
Device Name	SPINOUS PROCESS FUSION (SPF) PLATE
Applicant	SPINAL SIMPLICITY, LLC 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	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2014
Decision Date	01/09/2015
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