FDA 510(k)

回應 5.5/6.0 穿刺螺釘系統

K 號：K222105 · 2023-03-23

決定日期2023-03-23

產品代碼NKB

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決定相當於

器材摘要

RESPONSE 5.5/6.0 Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222105. 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 RESPONSE 5.5/6.0 Cannulated Screw System?

RESPONSE 5.5/6.0 Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K222105.

When did RESPONSE 5.5/6.0 Cannulated Screw System receive FDA 510(k) clearance?

RESPONSE 5.5/6.0 Cannulated Screw System received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222105.

Who is the listed applicant for RESPONSE 5.5/6.0 Cannulated Screw System?

FDA 510(k) 記錄將 OrthoPediatrics Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for RESPONSE 5.5/6.0 Cannulated Screw System?

The FDA product code for RESPONSE 5.5/6.0 Cannulated Screw System is NKB.

其他以 OrthoPediatrics Corp. 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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