FDA 510(k)

Vitoss雙模態骨移植代用品泡沫條

K 號：K153608 · 2016-02-12

決定日期2016-02-12

產品代碼MQV

諮詢委員會或

決定相當於

器材摘要

Vitoss BiModal Bone Graft Substitute Foam Strip is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153608. 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 Vitoss BiModal Bone Graft Substitute Foam Strip?

Vitoss BiModal Bone Graft Substitute Foam Strip is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Orthovita, Inc.. The 510(k) number is K153608.

When did Vitoss BiModal Bone Graft Substitute Foam Strip receive FDA 510(k) clearance?

Vitoss BiModal Bone Graft Substitute Foam Strip received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153608.

Who is the listed applicant for Vitoss BiModal Bone Graft Substitute Foam Strip?

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

What is the FDA product code for Vitoss BiModal Bone Graft Substitute Foam Strip?

The FDA product code for Vitoss BiModal Bone Graft Substitute Foam Strip is MQV.

其他以 Orthovita, 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。

K163621Vitoss 生物活性（BA）注射劑 K161447HydroSet XT

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.

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