FDA 510(k)

MONTAGE-QS 可調節，可吸收骨膠

K 號：K231475 · 2023-10-12

決定日期2023-10-12

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

MONTAGE-QS Settable, Resorbable 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 2023-10-12 under 510(k) number K231475. 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 MONTAGE-QS Settable, Resorbable Bone Putty?

MONTAGE-QS Settable, Resorbable Bone Putty is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Orthocon, Inc.. The 510(k) number is K231475.

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

MONTAGE-QS Settable, Resorbable Bone Putty received FDA 510(k) clearance on 2023-10-12, under 510(k) number K231475.

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

The FDA product code for MONTAGE-QS Settable, Resorbable 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.K241027Permatage 可調骨膠Orthocon, Inc.K232771蒙特奇流動可調骨膠膠泥Orthocon, Inc.

官方來源

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