FDA 510(k)

Xultan 5.5 頸椎螺釘系統

K 號：K170108 · 2017-05-02

決定日期2017-05-02

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Xultan 5.5 Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K170108. 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 Xultan 5.5 Pedicle Screw System?

Xultan 5.5 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Met One Technologies. The 510(k) number is K170108.

When did Xultan 5.5 Pedicle Screw System receive FDA 510(k) clearance?

Xultan 5.5 Pedicle Screw System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170108.

Who is the listed applicant for Xultan 5.5 Pedicle Screw System?

The FDA 510(k) record lists Met One Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xultan 5.5 Pedicle Screw System?

The FDA product code for Xultan 5.5 Pedicle Screw System is NKB.

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相關器械（代碼：NKB）

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