510(k) K173960

DePuy Corail AMT Hip Prosthesis by Depuy France S.A.S. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2018
Date Received
December 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type