FDA 510(k) Application Details - K173491

Device Classification Name	Prosthesis, Toe, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K173491
Device Name	Prosthesis, Toe, Constrained, Polymer
Applicant	In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Rebecca Wahl 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	11/13/2017
Decision Date	02/23/2018
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