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FDA 510(k)

Vitoss® 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® 生物活性骨移植代用品包裝，Vitoss® 生物活性骨移植代用品，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，Vitoss® 骨移植代用品 - 合成多孔片

K 號：K242280 · 2024-08-29

申請人Stryker Spine
決定日期2024-08-29
產品代碼MQV
諮詢委員會或
決定相當於

器材摘要

Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K242280. 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 Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips?

Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Stryker Spine. The 510(k) number is K242280.

When did Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips receive FDA 510(k) clearance?

Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips received FDA 510(k) clearance on 2024-08-29, under 510(k) number K242280.

Who is the listed applicant for Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips?

FDA 510(k) 記錄將 Stryker Spine 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips?

The FDA product code for Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips 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 Stryker Spine 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。

K262061Tritanium® C 頸椎前方金層；Tritanium® PL 金層；Tritanium® TL 弯曲後腰金層；Aero® -C 頸椎金層系統；AVS® Anchor-C 頸椎金層系統；AVS® TL PEEK 间隔器；AVS® PL PEEK 间隔器；AVS® Navigator PEEK 间隔器；AVS® AS PEEK 间隔器；Monterey™ AL 間體系統；Aleutian IBF 系統；Cascadia 間體系統；Chesapeake 稳定系統；Sahara 稳定系統；SANTORINI™ 去骨金層系統；MOJAVE 間體系統；VLIFT VERTEBRAL BODY REPLACEMK261008Vitoss® 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K242361OZARK脊椎板系統；PYRENEES®脊椎板系統；EVEREST®脊椎系統；MESA®脊椎系統；MESA®矮身材脊椎系統；CASPIAN®脊椎系統；DENALI®脊椎系統；DENALI® MI脊椎系統；YUKON OCT脊椎系統；Xia® 3脊椎系統；K2M病人專屬；CASCADIA™間體系統；CAYMAN®板系統；CAYMAN®板系統-MIK222684XIA® 4.5脊椎系統，XIA® 4.5皮質軌跡，XIA® 3脊椎系統，Serrato®脊椎系統，XIA®成長桿轉換組，XIA® II脊椎系統，XIA®精準系統，XIA®前側，Diapason®脊椎系統，Opus™脊椎系統，Radius®脊椎系統，Mantis®脊椎系統，Mantis® Redux，Trio® & Trio+脊椎固定系統，ES2™脊椎系統，ES2™可擴充脊椎系統，Oasys®枕頸胸系統，Nile®近端固定脊椎系統，Nile®替代固定脊椎系統K221490Tritanium C 頸椎前方金層，Tritanium PL 金層，Tritanium TL 弯曲後腰金層，Tritanium X PL 可擴張後腰金層，Tritanium X TL 可擴張弯曲後腰金層，Stryker Spine VLIFT 骨體置換系統，VLIFT-s 骨體置換系統，Ascential IBD PEEKc Spacer，Aero-AL 腰椎金層系統，Aero-LL 腰椎金層系統，Aero-C 頸椎金層系統，AVS Aria PEEK Spacer，AVS Anchor-C 頸椎金層系統，AVS Anchor-L SpacerK203205導航脊椎儀器

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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.

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