FDA 510(k)

AOS小骨折プレートシステム

K番号: K161913 · 2016-11-04

申請者Advanced Orthopaedic Solutions, Inc. (Aos)

決定日2016-11-04

製品コードHRS

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

AOS Small Fragment Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161913. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the AOS Small Fragment Plating System?

AOS Small Fragment Plating System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K161913.

When did AOS Small Fragment Plating System receive FDA 510(k) clearance?

AOS Small Fragment Plating System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161913.

Who is the listed applicant for AOS Small Fragment Plating System?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. (Aos) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS Small Fragment Plating System?

The FDA product code for AOS Small Fragment Plating System is HRS.

申請者としてAdvanced Orthopaedic Solutions, Inc. (Aos)を記載するその他の記録

K181035AOS小骨折プレートシステムライト K171606AOS前外側近位上腕骨プレート K163014AOS小骨釘システム

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