FDA 510(k)

PEEK脊椎輸液籠

K 號：K223776 · 2023-03-03

申請人Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

決定日期2023-03-03

產品代碼MAX

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決定相當於

器材摘要

PEEK Spinal Infusion Cage is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K223776. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PEEK Spinal Infusion Cage?

PEEK Spinal Infusion Cage is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. The 510(k) number is K223776.

When did PEEK Spinal Infusion Cage receive FDA 510(k) clearance?

PEEK Spinal Infusion Cage received FDA 510(k) clearance on 2023-03-03, under 510(k) number K223776.

Who is the listed applicant for PEEK Spinal Infusion Cage?

The FDA 510(k) record lists Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEK Spinal Infusion Cage?

The FDA product code for PEEK Spinal Infusion Cage is MAX.

其他以 Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. 為申請人之記錄

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相關器械（代碼：MAX）

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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