FDA 510(k)

无菌可吸收骨釘（可吸收ACL釘）

K 號：K210122 · 2021-08-27

決定日期2021-08-27

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

Sterile Bioabsorbable bone screw (Bioabsorbable 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 2021-08-27 under 510(k) number K210122. 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 Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)?

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K210122.

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

Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210122.

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

The FDA product code for Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) is MAI.

其他以 Osteonic Co., Ltd. 為申請人之記錄

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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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