FDA 510(k)

謹慎個別化金屬顎面網狀植入體

K 號：K232889 · 2024-04-30

決定日期2024-04-30

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

METICULY Patient-specific titanium maxillofacial mesh implant is the device name listed in this FDA 510(k) record. The listed applicant is Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K232889. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the METICULY Patient-specific titanium maxillofacial mesh implant?

METICULY Patient-specific titanium maxillofacial mesh implant is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K232889.

When did METICULY Patient-specific titanium maxillofacial mesh implant receive FDA 510(k) clearance?

METICULY Patient-specific titanium maxillofacial mesh implant received FDA 510(k) clearance on 2024-04-30, under 510(k) number K232889.

Who is the listed applicant for METICULY Patient-specific titanium maxillofacial mesh implant?

FDA 510(k) 記錄將 Meticuly Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant?

The FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant is JEY.

其他以 Meticuly Co., Ltd. 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：JEY）

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。

K260137KLS Martin IPS 口腔-馬克斯植入物 - MR條件性；個人患者解決方案 - Ti (IPS-Ti)；個人患者解決方案 - PEEK (IPS-PEEK)；KLS Martin 個人患者解決方案KLS-Martin L.P.K253206謹慎個別化CMF解決方案Meticuly Co., Ltd.K252246萊福特MMF系統Jeil Medical Corporation K253373南頸顎面骨系統Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 婴兒生物可吸收固定系統；Inion CPS 1.5/2.0/2.5 生物可吸收固定系統Inion OY K241314KLS Martin 口腔-馬克斯植入物 MR條件性（組合式）KLS-Martin L.P.

官方來源

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