FDA 510(k)

SI-Cure 腰骨盆関節融合システム

K番号: K223819 · 2023-01-18

決定日2023-01-18

製品コードOUR

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

SI-Cure Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Alevio, LLC. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K223819. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SI-Cure Sacroiliac Joint Fusion System?

SI-Cure Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Alevio, LLC. The 510(k) number is K223819.

When did SI-Cure Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

SI-Cure Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2023-01-18, under 510(k) number K223819.

Who is the listed applicant for SI-Cure Sacroiliac Joint Fusion System?

The FDA 510(k) record lists Alevio, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SI-Cure Sacroiliac Joint Fusion System?

The FDA product code for SI-Cure Sacroiliac Joint Fusion System is OUR.

申請者としてAlevio, LLCを記載するその他の記録

K231951SI-Cure 腰骨盆関節融合システム

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