FDA 510(k)

Permatage 可調骨膠

K 號：K241027 · 2024-09-26

決定日期2024-09-26

產品代碼GXP

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

Permatage Settable Bone Putty is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241027. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Permatage Settable Bone Putty?

Permatage Settable Bone Putty is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Orthocon, Inc.. The 510(k) number is K241027.

When did Permatage Settable Bone Putty receive FDA 510(k) clearance?

Permatage Settable Bone Putty received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241027.

Who is the listed applicant for Permatage Settable Bone Putty?

FDA 510(k) 記錄將 Orthocon, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Permatage Settable Bone Putty?

The FDA product code for Permatage Settable Bone Putty is GXP.

其他以 Orthocon, 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。

K262769Permatage XT 可調節不吸收性止血骨膠 (OS-PER-1001XT)K261265Permatage XT 可調節骨膠 K261439Permatage 流動性可調節止血骨膠 K253447Montage 流動式可調節，可吸收骨膠（噴孔蓋）K253732Permatage 流動性可調骨膠 K253854MONTAGE XT 頭蓋骨水泥

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相關器械（代碼：GXP）

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。

K251959TnR 頭蓋內植器T&R BIOFAB CO., Ltd.K261265Permatage XT 可調節骨膠Orthocon, Inc.K253732Permatage 流動性可調骨膠Orthocon, Inc.K253854MONTAGE XT 頭蓋骨水泥Orthocon, Inc.K232771蒙特奇流動可調骨膠膠泥Orthocon, Inc.K231475MONTAGE-QS 可調節，可吸收骨膠Orthocon, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。