FDA 510(k) Application Details - K142643

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K142643
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	D3 DC, LLC /Stabilynx, Inc 3475-0 Edison Way Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Mike Rosenthal Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2014
Decision Date	12/15/2014
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