FDA 510(k)

多孔生物支架

K 號：K250556 · 2025-03-21

決定日期2025-03-21

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Porous Biologic Scaffold is the device name listed in this FDA 510(k) record. The listed applicant is Ventris Medical. It received FDA 510(k) clearance on 2025-03-21 under 510(k) number K250556. 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 Porous Biologic Scaffold?

Porous Biologic Scaffold is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Ventris Medical. The 510(k) number is K250556.

When did Porous Biologic Scaffold receive FDA 510(k) clearance?

Porous Biologic Scaffold received FDA 510(k) clearance on 2025-03-21, under 510(k) number K250556.

Who is the listed applicant for Porous Biologic Scaffold?

The FDA 510(k) record lists Ventris Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Porous Biologic Scaffold?

The FDA product code for Porous Biologic Scaffold is MQV.

其他以 Ventris Medical 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。

K260596膠原蛋白傷口粉末 K240765多孔生物支架 K240458人工骨膠 K221644人工骨膠

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 AG K252797JAZBI™ 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 Spine K253524Adaptos®Fuse Bone GraftBiomendex OY K253147FIBERGRAFT™ 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。