FDA 510(k)

リガメトリックス缝合锚

K番号: K171964 · 2017-09-19

決定日2017-09-19

製品コードMBI

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

LigaMetrics Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Mortise Medical, LLC. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K171964. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the LigaMetrics Suture Anchors?

LigaMetrics Suture Anchors is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Mortise Medical, LLC. The 510(k) number is K171964.

When did LigaMetrics Suture Anchors receive FDA 510(k) clearance?

LigaMetrics Suture Anchors received FDA 510(k) clearance on 2017-09-19, under 510(k) number K171964.

Who is the listed applicant for LigaMetrics Suture Anchors?

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

What is the FDA product code for LigaMetrics Suture Anchors?

The FDA product code for LigaMetrics Suture Anchors is MBI.

申請者としてMortise Medical, LLCを記載するその他の記録

K172620SyndesMetrics 骨折修復システム

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