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FDA 510(k)

Nebula品牌固定骨板和螺釘骨合術板釘系統，Nebula品牌DHS板釘系統

K 號：K191793 · 2019-12-09

申請人Nebula Surgical Private Limited
決定日期2019-12-09
產品代碼HRS
諮詢委員會或
決定相當於

器材摘要

Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Nebula Surgical Private Limited. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K191793. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System?

Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Nebula Surgical Private Limited. The 510(k) number is K191793.

When did Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System receive FDA 510(k) clearance?

Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System received FDA 510(k) clearance on 2019-12-09, under 510(k) number K191793.

Who is the listed applicant for Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System?

The FDA 510(k) record lists Nebula Surgical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System?

The FDA product code for Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System is HRS.

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

相關器械（代碼：HRS）

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。

K261892ProRib固定系統Costa Surgical, Inc.K262098EnHAnce PEEK 趾骨隆起系統Nvision Biomedical TechnologiesK262963TMC 偽骨固定系統Treace Medical Concepts, Inc.K261647Tempo植板系統；超壓縮螺釘系統Pace SurgicalK261830FRAXION 3.5 板系統（多種 - 見目錄）；FRAXION 4.5 板系統（多種 - 見目錄）；FRAXION Mini 板系統（多種 - 見目錄）；FRAXION 骨釘系統（多種 - 見目錄）Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock 無菌板片系統GM Dos Reis Industria e Comercio Ltda.

官方來源

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