FDA 510(k)

花縫合釘組

K 號：K192949 · 2020-10-07

決定日期2020-10-07

產品代碼MBI

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決定相當於

器材摘要

Flower Suture Anchor Set is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K192949. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flower Suture Anchor Set?

Flower Suture Anchor Set is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K192949.

When did Flower Suture Anchor Set receive FDA 510(k) clearance?

Flower Suture Anchor Set received FDA 510(k) clearance on 2020-10-07, under 510(k) number K192949.

Who is the listed applicant for Flower Suture Anchor Set?

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

What is the FDA product code for Flower Suture Anchor Set?

The FDA product code for Flower Suture Anchor Set is MBI.

其他以 Flower Orthopedics Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170687花骨釘組套

相關器械（代碼：MBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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