FDA 510(k)

CarboClear® X 頸椎螺釘系統；CarboClear® X 經導儀器

K 號：K233944 · 2024-01-10

決定日期2024-01-10

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments 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 2024-01-10 under 510(k) number K233944. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments?

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments is a medical device that received FDA 510(k) clearance on 2024-01-10. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K233944.

When did CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments receive FDA 510(k) clearance?

CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments received FDA 510(k) clearance on 2024-01-10, under 510(k) number K233944.

Who is the listed applicant for CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments?

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 CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments?

The FDA product code for CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments is NKB.

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 K232341CarboClear® 頸椎螺釘系統

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相關器械（代碼：NKB）

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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官方來源

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