Cleared Traditional

CONQUEST FN

K152686 · Smith & Nephew · Orthopedic
Mar 2016
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K152686 is an FDA 510(k) clearance for the CONQUEST FN, a Device, Fixation, Proximal Femoral, Implant (Class II — Special Controls, product code JDO), submitted by Smith & Nephew (Memphis, US). The FDA issued a Cleared decision on March 17, 2016, 181 days after receiving the submission on September 18, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K152686 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2015
Decision Date March 17, 2016
Days to Decision 181 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDO — Device, Fixation, Proximal Femoral, Implant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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