FDA 510(k)

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

K-Number: K201527 · 2020-07-22

Decision Date2020-07-22

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) 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 2020-07-22 under 510(k) 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. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K201527.

When did EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) receive FDA 510(k) clearance?

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

Who is the listed applicant for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)?

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 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.

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Other records listing Smith & Nephew, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.