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FDA 510(k)

EVOS Small Fragment Plating System

K-Number: K162078 · 2016-11-18

ApplicantSmith & Nephew, Inc.
Decision Date2016-11-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Small Fragment Plating System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-18 under approval 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. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K162078.

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

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

What company makes EVOS Small Fragment Plating System?

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

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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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

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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.

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