Cleared Traditional

K193029 - CONQUEST FN
(FDA 510(k) Clearance)

K193029 · Smith & Nephew, Inc. · Orthopedic

Feb 2020

Decision

121d

Days

Class 2

Risk

K193029 is an FDA 510(k) clearance for the CONQUEST FN. This device is classified as a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO).

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on February 28, 2020, 121 days after receiving the submission on October 30, 2019.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K193029 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2019
Decision Date	February 28, 2020
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF