FDA 510(k)

EVOS Small Fragment Upper Extremity Plates Line Additions

K-Number: K190253 · 2019-03-11

Decision Date2019-03-11

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOS Small Fragment Upper Extremity Plates Line Additions is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-03-11 under approval number K190253. 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 Line Additions?

EVOS Small Fragment Upper Extremity Plates Line Additions is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K190253.

When was EVOS Small Fragment Upper Extremity Plates Line Additions approved by the FDA?

EVOS Small Fragment Upper Extremity Plates Line Additions received FDA 510(k) clearance on 2019-03-11, under approval number K190253.

What company makes EVOS Small Fragment Upper Extremity Plates Line Additions?

EVOS Small Fragment Upper Extremity Plates Line Additions is manufactured by Smith & Nephew, Inc..

What is the FDA product code for EVOS Small Fragment Upper Extremity Plates Line Additions?

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