FDA 510(k)

高V+骨水泥，CarboClear®窗孔椎板螺釘

K 號：K190526 · 2019-09-19

決定日期2019-09-19

產品代碼PML

諮詢委員會或

決定相當於

器材摘要

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2019-09-19 under 510(k) number K190526. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K190526.

When did High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws receive FDA 510(k) clearance?

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws received FDA 510(k) clearance on 2019-09-19, under 510(k) number K190526.

Who is the listed applicant for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

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

What is the FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws?

The FDA product code for High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws is PML.

其他以 CarboFix Orthopedics , Ltd. 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。

K254045CarboClear® 頸椎後路螺釘系統；CarboClear® 混合後路螺釘系統 K243106CarboClear®雙柱體螺釘系統 K233793CarboClear® X 頸椎螺釘系統 K240846CarboClear®雙模組椎板釘系統；CarboClear®雙模組導航工具；CarboClear®雙模組窗孔椎板釘系統及High V+®骨水泥；CarboClear®X窗孔椎板釘系統及High V+®骨水泥 K233989CarboClear® 頸椎後路螺釘系統 K233944CarboClear® X 頸椎螺釘系統；CarboClear® X 經導儀器

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相關器械（代碼：PML）

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。

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