FDA 510(k)

EVOS Small Fragment Upper Extremity Plates

K-Number: K173293 · 2018-01-08

Decision Date2018-01-08

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOS Small Fragment Upper Extremity Plates 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 2018-01-08 under 510(k) number K173293. 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 Upper Extremity Plates?

EVOS Small Fragment Upper Extremity Plates is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K173293.

When did EVOS Small Fragment Upper Extremity Plates receive FDA 510(k) clearance?

EVOS Small Fragment Upper Extremity Plates received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173293.

Who is the listed applicant for EVOS Small Fragment Upper Extremity Plates?

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 Upper Extremity Plates?

The FDA product code for EVOS Small Fragment Upper Extremity Plates is HRS.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: HRS)

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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.