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FDA 510(k)

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

K-Number: K201527 · 2020-07-22

ApplicantSmith & Nephew, Inc.
Decision Date2020-07-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-07-22 under approval number K201527. 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 Straight Proximal Humerus 7-15 hole Plates (137-225mm)?

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K201527.

When was EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) approved by the FDA?

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) received FDA 510(k) clearance on 2020-07-22, under approval number K201527.

What company makes EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)?

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) is manufactured by Smith & Nephew, Inc..

What is the FDA product code for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)?

The FDA product code for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) is HRS.

Related Clinical Trials

NCT01866501 Follow-Up Study Validating a Blended Technique to Identify the Proximal Humerus Intraosseous Vascular Access Site COMPLETED NCT01866514 Proximal Humerus Site for Anesthesia COMPLETED

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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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