FDA 510(k)

EVOS Small Fragment Plating System

K-Number: K162078 · 2016-11-18

Decision Date2016-11-18

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOS Small Fragment Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162078. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOS Small Fragment Plating System?

EVOS Small Fragment Plating System is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162078.

When did EVOS Small Fragment Plating System receive FDA 510(k) clearance?

EVOS Small Fragment Plating System received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162078.

Who is the listed applicant for EVOS Small Fragment Plating System?

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

What is the FDA product code for EVOS Small Fragment Plating System?

The FDA product code for EVOS Small Fragment Plating System is HRS.

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Other records listing Smith & Nephew, Inc. 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: HRS)

K261511Xpert AnkleNewclip Technics K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip Technics K261054RibPlate SystemStryker Leibinger GmbH & Co KG K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG

Official Source

View on FDA Database →

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