FDA 510(k)

无菌骨螺釘（PEEK ACL 螺釘）

K 號：K202883 · 2020-11-25

決定日期2020-11-25

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Sterile bone screw (PEEK ACL screw) 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 2020-11-25 under 510(k) number K202883. 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 Sterile bone screw (PEEK ACL screw)?

Sterile bone screw (PEEK ACL screw) is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K202883.

When did Sterile bone screw (PEEK ACL screw) receive FDA 510(k) clearance?

Sterile bone screw (PEEK ACL screw) received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202883.

Who is the listed applicant for Sterile bone screw (PEEK ACL screw)?

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 Sterile bone screw (PEEK ACL screw)?

The FDA product code for Sterile bone screw (PEEK ACL screw) is MBI.

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)K243467Fix2Lock (生物複合材內側，生物複合材側邊，生物複合材自擊釘)K230546SIGNEX K233659縫合翼

查看所有 18 項裝置 →

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

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。