FDA 510(k)

MediRod 椎板螺釘系統

K 號：K242764 · 2024-11-13

決定日期2024-11-13

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

MediRod Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Cmf Medicon Surgical, Inc.. It received FDA 510(k) clearance on 2024-11-13 under 510(k) number K242764. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MediRod Pedicle Screw System?

MediRod Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K242764.

When did MediRod Pedicle Screw System receive FDA 510(k) clearance?

MediRod Pedicle Screw System received FDA 510(k) clearance on 2024-11-13, under 510(k) number K242764.

Who is the listed applicant for MediRod Pedicle Screw System?

The FDA 510(k) record lists Cmf Medicon Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MediRod Pedicle Screw System?

The FDA product code for MediRod Pedicle Screw System is NKB.

其他以 Cmf Medicon Surgical, Inc. 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。

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相關器械（代碼：NKB）

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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