FDA 510(k)

CITRELOCK® 杜魯克

K 號：K232592 · 2023-09-20

決定日期2023-09-20

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

CITRELOCK® DUO 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 2023-09-20 under 510(k) number K232592. 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 CITRELOCK® DUO?

CITRELOCK® DUO is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Acuitive Technologies, Inc.. The 510(k) number is K232592.

When did CITRELOCK® DUO receive FDA 510(k) clearance?

CITRELOCK® DUO received FDA 510(k) clearance on 2023-09-20, under 510(k) number K232592.

Who is the listed applicant for CITRELOCK® DUO?

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 CITRELOCK® DUO?

The FDA product code for CITRELOCK® DUO is MBI.

其他以 Acuitive Technologies, Inc. 為申請人之記錄

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K240450Citrepore™K221468Citregen™ 軟骨干擾螺釘 (TIS)，Citrelock™ 軟骨固定裝置，CitreSpline™ 及 Citrelock™ ACL 假體 K220833Citregen 軟骨干擾螺釘、Citrelock、Citrefix、CitreSpline ACL 及 Citrelock ACL K210239CITRESPLINE 及 CITRELOCK ACL 假體 K203334Citrefix 間隙無縫針锚

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

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