FDA 510(k)

MONTAGE-XT 可調節、可吸收性止血骨膠

K 號：K220315 · 2022-03-11

決定日期2022-03-11

產品代碼MTJ

決定相當於

器材摘要

MONTAGE-XT Settable, Resorbable Hemostatic 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 2022-03-11 under 510(k) number K220315. The device is classified under product code MTJ. FDA Decision: Substantially Equivalent.

常見問題

What is the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty?

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Orthocon, Inc.. The 510(k) number is K220315.

When did MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty receive FDA 510(k) clearance?

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance on 2022-03-11, under 510(k) number K220315.

Who is the listed applicant for MONTAGE-XT Settable, Resorbable Hemostatic 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 MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty?

The FDA product code for MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 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.K231386Montage 流動性 XRO 設定式，可吸收止血骨膠Orthocon, Inc.K200452美瑞-骨蠟M/s. Meril Endo Surgery Private Limited.

官方來源

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