FDA 510(k)

斯特羅曼®解剖式癒合基座XC (AHA)

K 號：K241575 · 2024-11-11

決定日期2024-11-11

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Straumann® Anatomic Healing Abutments XC (AHA) is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2024-11-11 under 510(k) number K241575. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Straumann® Anatomic Healing Abutments XC (AHA)?

Straumann® Anatomic Healing Abutments XC (AHA) is a medical device that received FDA 510(k) clearance on 2024-11-11. The listed applicant is Straumann USA, LLC. The 510(k) number is K241575.

When did Straumann® Anatomic Healing Abutments XC (AHA) receive FDA 510(k) clearance?

Straumann® Anatomic Healing Abutments XC (AHA) received FDA 510(k) clearance on 2024-11-11, under 510(k) number K241575.

Who is the listed applicant for Straumann® Anatomic Healing Abutments XC (AHA)?

The FDA 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann® Anatomic Healing Abutments XC (AHA)?

The FDA product code for Straumann® Anatomic Healing Abutments XC (AHA) is NHA.

其他以 Straumann USA, LLC 為申請人之記錄

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相關器械（代碼：NHA）

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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