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FDA 510(k)

EVOS Large Fragment Plating System

K-Number: K203405 · 2021-01-27

ApplicantSmith & Nephew, Inc.
Decision Date2021-01-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Large Fragment Plating System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-01-27 under approval number K203405. 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 Large Fragment Plating System?

EVOS Large Fragment Plating System is a medical device that received FDA 510(k) clearance on 2021-01-27. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K203405.

When was EVOS Large Fragment Plating System approved by the FDA?

EVOS Large Fragment Plating System received FDA 510(k) clearance on 2021-01-27, under approval number K203405.

What company makes EVOS Large Fragment Plating System?

EVOS Large Fragment Plating System is manufactured by Smith & Nephew, Inc..

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

The FDA product code for EVOS Large Fragment Plating System 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.

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