FDA 510(k)

Citregen 軟骨干擾螺釘、Citrelock、Citrefix、CitreSpline ACL 及 Citrelock ACL

K 號：K220833 · 2022-11-04

決定日期2022-11-04

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is the device name listed in this FDA 510(k) record. The listed applicant is Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K220833. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Acuitive Technologies, Inc.. The 510(k) number is K220833.

When did Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL receive FDA 510(k) clearance?

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL received FDA 510(k) clearance on 2022-11-04, under 510(k) number K220833.

Who is the listed applicant for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

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

What is the FDA product code for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

The FDA product code for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is MAI.

其他以 Acuitive Technologies, Inc. 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。

K240450Citrepore™K232592CITRELOCK® 杜魯克 K221468Citregen™ 軟骨干擾螺釘 (TIS)，Citrelock™ 軟骨固定裝置，CitreSpline™ 及 Citrelock™ ACL 假體 K210239CITRESPLINE 及 CITRELOCK ACL 假體 K203334Citrefix 間隙無縫針锚

相關器械（代碼：MAI）

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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