FDA 510(k) Application Details - K153095

Device Classification Name	Wax,Bone   More FDA Info for this Device
510(K) Number	K153095
Device Name	Wax,Bone
Applicant	Resorbable Orthopedic Products, LLC 16633 Dallas Parkway, Suite 250 Addison, TX 75001 US Other 510(k) Applications for this Company
Contact	Barry E Constantine Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/26/2015
Decision Date	02/17/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review