FDA 510(k)

Dunamis PunchTac 識別器

K 號：K193245 · 2020-02-14

決定日期2020-02-14

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Dunamis PunchTac Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Dunamis, LLC. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K193245. 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 Dunamis PunchTac Suture Anchors?

Dunamis PunchTac Suture Anchors is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Dunamis, LLC. The 510(k) number is K193245.

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

Dunamis PunchTac Suture Anchors received FDA 510(k) clearance on 2020-02-14, under 510(k) number K193245.

Who is the listed applicant for Dunamis PunchTac Suture Anchors?

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

What is the FDA product code for Dunamis PunchTac Suture Anchors?

The FDA product code for Dunamis PunchTac Suture Anchors is MBI.

其他以 Dunamis, LLC 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。

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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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