FDA 510(k)

Normatec Elite 髖部

K 號：K251905 · 2025-09-18

決定日期2025-09-18

產品代碼IRP

諮詢委員會PM

決定相當於

器材摘要

Normatec Elite Hip is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K251905. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Normatec Elite Hip?

Normatec Elite Hip is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is NormaTec Industries, LP. The 510(k) number is K251905.

When did Normatec Elite Hip receive FDA 510(k) clearance?

Normatec Elite Hip received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251905.

Who is the listed applicant for Normatec Elite Hip?

The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Normatec Elite Hip?

The FDA product code for Normatec Elite Hip is IRP.

其他以 NormaTec Industries, LP 為申請人之記錄

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相關器械（代碼：IRP）

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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