FDA 510(k)

CONQUEST FN

K-Number: K152686 · 2016-03-17

Decision Date2016-03-17

Product CodeJDO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CONQUEST FN is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2016-03-17 under 510(k) number K152686. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONQUEST FN?

CONQUEST FN is a medical device that received FDA 510(k) clearance on 2016-03-17. The listed applicant is Smith & Nephew. The 510(k) number is K152686.

When did CONQUEST FN receive FDA 510(k) clearance?

CONQUEST FN received FDA 510(k) clearance on 2016-03-17, under 510(k) number K152686.

Who is the listed applicant for CONQUEST FN?

The FDA 510(k) record lists Smith & Nephew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONQUEST FN?

The FDA product code for CONQUEST FN is JDO.

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Other records listing Smith & Nephew as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: JDO)

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma K193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.