510(k) K173960

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

K173960 is an FDA 510(k) premarket notification submitted by Depuy France S.A.S. for the device "DePuy Corail AMT Hip Prosthesis". The FDA issued a decision of Substantially Equivalent on Sep 21, 2018. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Depuy France S.A.S. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 21, 2018
Date Received
Dec 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
510(k)