Conquest FN

FDA 510(k) K152686 · Smith & Nephew

Substantially Equivalent

510(k) numberK152686

Submission

Device name
Conquest FN
Applicant
Smith & Nephew
Memphis, TN, US
Received
September 18, 2015
Decision date
March 17, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDO – Device, Fixation, Proximal Femoral, Implant
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code JDO

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K230764OsteoCentric Integrated Hip Fastener SystemJDO · Special OsteoCentric Technologies04/18/2023SE
K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional Smith & Nephew, Inc.09/29/2022SE
K210247OsteoCentric Integrated Hip Fastener SystemJDO · Traditional Osteocentric Technologies D.B.A. Osteocentric…04/30/2021SE
K193029Conquest FNJDO · Traditional Smith & Nephew, Inc.02/28/2020SE
K173826THP Hip Fracture Plating SystemJDO · Traditional Biomet, Inc.02/07/2018SE
K172785Conquest FNJDO · Special Smith & Nephew12/22/2017SE
K140018TSP Hip Fracture Plating SystemJDO · Traditional Biomet, Inc.04/04/2014SE
K080685Hiploc Compression Hip ScrewJDO · Traditional Biomet Manufacturing, Inc.08/15/2008SE
K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional Smith & Nephew, Inc.04/10/2008SE
K983814Gotfried Percutaneous Compression Plating SystemJDO · Traditional Efratgo, Ltd. HI Tech Bio-Surgical01/14/1999SE

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Questions and answers

When was Conquest FN cleared by the FDA?

Conquest FN (K152686) received a 510(k) decision of Substantially Equivalent on March 17, 2016, 181 days after the submission was received.

What is the product code of K152686?

The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.