FDA 510(k)

Sterispine™ PS

K 號：K201648 · 2020-07-30

決定日期2020-07-30

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Sterispine™ PS is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K201648. 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 Sterispine™ PS?

Sterispine™ PS is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Safe Orthopaedics. The 510(k) number is K201648.

When did Sterispine™ PS receive FDA 510(k) clearance?

Sterispine™ PS received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201648.

Who is the listed applicant for Sterispine™ PS?

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

What is the FDA product code for Sterispine™ PS?

The FDA product code for Sterispine™ PS is NKB.

其他以 Safe Orthopaedics 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。

K170528Sterispine™ PS K162531STERISPINE CC

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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