FDA 510(k)

SI-TECHNOLOGY® SI-DESIS® X™ 脊髄骨盆関節融合システム

K番号: K241813 · 2024-08-13

決定日2024-08-13

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-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Si-Technology, LLC. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241813. 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-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Si-Technology, LLC. The 510(k) number is K241813.

When did SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241813.

Who is the listed applicant for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

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

What is the FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

The FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is OUR.

申請者としてSi-Technology, LLCを記載するその他の記録

K251525SI-TECHNOLOGY® SI-DESIS® X™ 脊髄骨盆関節融合システム

公式ソース

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