510(k) K193029

CONQUEST FN by Smith & Nephew, Inc. — Product Code JDO

K193029 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "CONQUEST FN". The FDA issued a decision of Substantially Equivalent on February 28, 2020. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2020
Date Received
October 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type