免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

MONTAGE 可調節，可吸收骨膠 MONTAGE-QS 可調節，可吸收骨膠 MONTAGE 流動可調節，可吸收骨膠泥 MONTAGE-XT 可調節，可吸收止血骨膠

K 號：K243526 · 2024-12-05

申請人Orthocon, Inc.
決定日期2024-12-05
產品代碼MQV
諮詢委員會或
決定相當於

器材摘要

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste 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 2024-12-05 under 510(k) number K243526. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Orthocon, Inc.. The 510(k) number is K243526.

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

MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty received FDA 510(k) clearance on 2024-12-05, under 510(k) number K243526.

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

The FDA product code for MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty is MQV.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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

查看所有 25 項裝置 →

相關器械（代碼：MQV）

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。

K262230Mg 骨回復™；Mg 骨凝合™Bone Solutions, Inc.K260364設備 300419 識別條Geistlich Pharma AGK252797JAZBI™ 可吸收骨空洞填充物Sdip Innovations Pty, Ltd.K261008Vitoss® BiModal 生物活性骨移植代用品泡沫條；Vitoss® BiModal 生物活性骨移植代用品；Vitoss BBTrauma® 生物活性骨移植代用品；Vitoss® BA2X 生物活性骨移植代用品；Vitoss® 生物活性泡沫骨移植代用品包；Vitoss® 生物活性泡沫骨移植代用品；Vitoss® 泡沫骨移植代用品；Vitoss® 骨移植代用品填充罐；Vitoss® 骨移植代用品Stryker SpineK253524Adaptos®Fuse Bone GraftBiomendex OYK253147FIBERGRAFT™ BG 黏土 GPS 骨移植代用品 FIBERGRAFT™ BG 黏土 骨移植代用品 FIBERGRAFT™ AERIDYAN™ 維網骨移植代用品 FIBERGRAFT™ BG 維網骨移植代用品Prosidyan, Inc.

官方來源

在 FDA 資料庫中查看 →

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。

↑