FDA 510(k)

STERISPINE CC

K 號：K162531 · 2016-12-29

決定日期2016-12-29

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

STERISPINE CC is the device name listed in this FDA 510(k) record. The listed applicant is Safe Orthopaedics. It received FDA 510(k) clearance on 2016-12-29 under 510(k) number K162531. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERISPINE CC?

STERISPINE CC is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is Safe Orthopaedics. The 510(k) number is K162531.

When did STERISPINE CC receive FDA 510(k) clearance?

STERISPINE CC received FDA 510(k) clearance on 2016-12-29, under 510(k) number K162531.

Who is the listed applicant for STERISPINE CC?

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 CC?

The FDA product code for STERISPINE CC is OVE.

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。

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相關器械（代碼：OVE）

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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