FDA 510(k)

Parcus Knotless PEEK及PEEK CF 推入縫合釘

K 號：K193295 · 2020-01-23

決定日期2020-01-23

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K193295. 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 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Parcus Medical, LLC. The 510(k) number is K193295.

When did Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor receive FDA 510(k) clearance?

Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor received FDA 510(k) clearance on 2020-01-23, under 510(k) number K193295.

Who is the listed applicant for Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?

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

What is the FDA product code for Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor?

The FDA product code for Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor is MBI.

其他以 Parcus Medical, LLC 為申請人之記錄

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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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官方來源

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