FDA 510(k)

Fix2Lock (生物複合材內側，生物複合材側邊，生物複合材自擊釘)

K 號：K243467 · 2024-12-03

決定日期2024-12-03

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2024-12-03 under 510(k) number K243467. 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 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is a medical device that received FDA 510(k) clearance on 2024-12-03. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K243467.

When did Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) receive FDA 510(k) clearance?

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) received FDA 510(k) clearance on 2024-12-03, under 510(k) number K243467.

Who is the listed applicant for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

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

What is the FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)?

The FDA product code for Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) is MAI.

其他以 Osteonic Co., Ltd. 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。

K254182Aster K243469SIGNEX K243470Fix2Lock (PEEK自擊打)K230546SIGNEX K233659縫合翼 K231322Fix2Lock(PEEK自擊打)

查看所有 18 項裝置 →

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。

K262357Arthrex 生物可吸收式 PushLock 縫線釘Arthrex, Inc.K253931Arthrex 生物可吸收式 PushLock 縫線釘Arthrex, Inc.K260294SF 推入式固定釘Surgical Fusion Technologies GmbH K254055OSSIOfiber® 緝線墊板OSSIO , Ltd.K251680Biosteon® 螺釘Biocomposites, Ltd.K252946BioBrace® 間節韌帶增強組合Conmed Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。