FDA 510(k) Application Details - K153609

Device Classification Name	Prosthesis, Toe, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K153609
Device Name	Prosthesis, Toe, Constrained, Polymer
Applicant	In2BonesUSA, LLC 6060 Poplar Ave, Suite 380 Mephis, TN 38119 US Other 510(k) Applications for this Company
Contact	Joe Clift Other 510(k) Applications for this Contact
Regulation Number	888.3720   More FDA Info for this Regulation Number
Classification Product Code	KWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2015
Decision Date	09/08/2016
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