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FDA 510(k)

大腿粗隆釘系統 – 新釘

K 號:K221021 · 2022-12-06

決定日期2022-12-06
產品代碼HSB
諮詢委員會或
決定相當於

器材摘要

Femoral Trochanteric Nail System – Neonail is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopédicos S/A. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K221021. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Femoral Trochanteric Nail System – Neonail?

Femoral Trochanteric Nail System – Neonail is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Neoortho Produtos Ortopédicos S/A. The 510(k) number is K221021.

When did Femoral Trochanteric Nail System – Neonail receive FDA 510(k) clearance?

Femoral Trochanteric Nail System – Neonail received FDA 510(k) clearance on 2022-12-06, under 510(k) number K221021.

Who is the listed applicant for Femoral Trochanteric Nail System – Neonail?

The FDA 510(k) record lists Neoortho Produtos Ortopédicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Femoral Trochanteric Nail System – Neonail?

The FDA product code for Femoral Trochanteric Nail System – Neonail is HSB.

相關臨床試驗

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相關器械(代碼:HSB)

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。

官方來源

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