FDA 510(k)

Montage 流動式可調節，可吸收骨膠（噴孔蓋）

K 號：K253447 · 2026-03-16

決定日期2026-03-16

產品代碼GXR

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 Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is the device name listed in this FDA 510(k) record. The listed applicant is Orthocon, Inc.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K253447. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Orthocon, Inc.. The 510(k) number is K253447.

When did Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) receive FDA 510(k) clearance?

Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253447.

Who is the listed applicant for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)?

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 Settable, Resorbable Bone Paste (Burr Hole Cover)?

The FDA product code for Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) is GXR.

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。

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相關器械（代碼：GXR）

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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