FDA 510(k)

融合顱顏植入體；融合顱骨植入體

K 號：K250334 · 2025-07-25

決定日期2025-07-25

產品代碼GWO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Fusion Craniofacial Implant; Fusion Skull Implant is the device name listed in this FDA 510(k) record. The listed applicant is Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K250334. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fusion Craniofacial Implant; Fusion Skull Implant?

Fusion Craniofacial Implant; Fusion Skull Implant is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K250334.

When did Fusion Craniofacial Implant; Fusion Skull Implant receive FDA 510(k) clearance?

Fusion Craniofacial Implant; Fusion Skull Implant received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250334.

Who is the listed applicant for Fusion Craniofacial Implant; Fusion Skull Implant?

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

What is the FDA product code for Fusion Craniofacial Implant; Fusion Skull Implant?

The FDA product code for Fusion Craniofacial Implant; Fusion Skull Implant is GWO.

其他以 Kelyniam Global, 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。

K182711自訂顱面植入物（CCI），自訂頭蓋植入物（CSI）

相關器械（代碼：GWO）

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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