FDA 510(k) Application Details - K171004

Device Classification Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K171004
Device Name	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Applicant	Dt MedTech LLC 110 West Road Suite 227 Towson, MD 21024 US Other 510(k) Applications for this Company
Contact	Shawn T Huxel Other 510(k) Applications for this Contact
Regulation Number	888.3110   More FDA Info for this Regulation Number
Classification Product Code	HSN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2017
Decision Date	11/07/2017
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