FDA 510(k)

通過OCT病人專屬桿子

K 號：K153169 · 2016-01-29

決定日期2016-01-29

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

PASS OCT Patient Specific Rods is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K153169. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PASS OCT Patient Specific Rods?

PASS OCT Patient Specific Rods is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Medicrea International. The 510(k) number is K153169.

When did PASS OCT Patient Specific Rods receive FDA 510(k) clearance?

PASS OCT Patient Specific Rods received FDA 510(k) clearance on 2016-01-29, under 510(k) number K153169.

Who is the listed applicant for PASS OCT Patient Specific Rods?

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

What is the FDA product code for PASS OCT Patient Specific Rods?

The FDA product code for PASS OCT Patient Specific Rods is NKG.

其他以 Medicrea International 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：NKG）

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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