FDA 510(k)

SI-Restore® 腰骨盆関節固定システム

K番号: K182919 · 2019-01-25

決定日2019-01-25

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-Restore® Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Biofusion Medical. It received FDA 510(k) clearance on 2019-01-25 under 510(k) number K182919. 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-Restore® Sacroiliac Joint Fixation System?

SI-Restore® Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Biofusion Medical. The 510(k) number is K182919.

When did SI-Restore® Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

SI-Restore® Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182919.

Who is the listed applicant for SI-Restore® Sacroiliac Joint Fixation System?

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

What is the FDA product code for SI-Restore® Sacroiliac Joint Fixation System?

The FDA product code for SI-Restore® Sacroiliac Joint Fixation System is OUR.

申請者としてBiofusion Medicalを記載するその他の記録

K200868SI-Restore 腰骨盆関節固定システム

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