FDA 510(k)

Montage 流動性 XRO 設定式，可吸收止血骨膠

K 號：K231386 · 2023-07-11

決定日期2023-07-11

產品代碼MTJ

決定相當於

器材摘要

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2023-07-11 under 510(k) number K231386. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

常見問題

What is the Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a medical device that received FDA 510(k) clearance on 2023-07-11. The listed applicant is Orthocon, Inc.. The 510(k) number is K231386.

When did Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste receive FDA 510(k) clearance?

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste received FDA 510(k) clearance on 2023-07-11, under 510(k) number K231386.

Who is the listed applicant for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

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 Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

The FDA product code for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is MTJ.

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：MTJ）

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)Orthocon, Inc.K261439Permatage 流動性可調節止血骨膠Orthocon, Inc.K232998Montage-XT 可調節，可吸收止血骨膠Orthocon, Inc.K213418MONTAGE 可調節、可吸收性止血骨膠Orthocon, Inc.K200452美瑞-骨蠟M/s. Meril Endo Surgery Private Limited.K220315MONTAGE-XT 可調節、可吸收性止血骨膠Orthocon, Inc.

官方來源

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