FDA 510(k)

Bonebridge 骨固定板系統

K 號：K213864 · 2022-09-02

決定日期2022-09-02

產品代碼HRS

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器材摘要

Bonebridge Osteosynthesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Bonebridge AG. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K213864. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bonebridge Osteosynthesis Plating System?

Bonebridge Osteosynthesis Plating System is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Bonebridge AG. The 510(k) number is K213864.

When did Bonebridge Osteosynthesis Plating System receive FDA 510(k) clearance?

Bonebridge Osteosynthesis Plating System received FDA 510(k) clearance on 2022-09-02, under 510(k) number K213864.

Who is the listed applicant for Bonebridge Osteosynthesis Plating System?

The FDA 510(k) record lists Bonebridge AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonebridge Osteosynthesis Plating System?

The FDA product code for Bonebridge Osteosynthesis Plating System is HRS.

其他以 Bonebridge AG 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。

K261351SALGINA 2.5mm 遠端桡骨系統 K260228POYA 3.5mm 靜脈近端胫骨系統 K252191BRUSIO 骨折工具箱系統；TAMINA 3.5mm 近端肱骨系統 K250933LORRAINE 2.5/3.5mm 遠端肱骨系統 K243308Bonebridge 骨固定板系統（SALGINA 2.5mm 遠端桡骨系統，CASCELLA 3.5mm 上位鎖骨系統，LEPORELLO 3.5mm 桡骨頭系統）K242399Bonebridge 骨固定板系統

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相關器械（代碼：HRS）

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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