FDA 510(k)

Striate+™

K 號：K201241 · 2021-01-11

決定日期2021-01-11

產品代碼NPL

諮詢委員會DE

決定相當於

器材摘要

Striate+™ is the device name listed in this FDA 510(k) record. The listed applicant is Orthocell, Ltd.. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K201241. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Striate+™?

Striate+™ is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Orthocell, Ltd.. The 510(k) number is K201241.

When did Striate+™ receive FDA 510(k) clearance?

Striate+™ received FDA 510(k) clearance on 2021-01-11, under 510(k) number K201241.

Who is the listed applicant for Striate+™?

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

What is the FDA product code for Striate+™?

The FDA product code for Striate+™ is NPL.

其他以 Orthocell, 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。

K243889填補 (ON-152, 15 x 20 mm)；填補 (ON-203, 20 x 30 mm)；填補 (ON-304, 30 x 40 mm)；填補 (ON-405, 40 x 50 mm)

相關器械（代碼：NPL）

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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