FDA 510(k)

NITINEX 記憶壓縮釘

K 號：K231493 · 2023-08-11

決定日期2023-08-11

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

NITINEX Memory Compression Staple is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231493. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NITINEX Memory Compression Staple?

NITINEX Memory Compression Staple is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Vilex, LLC. The 510(k) number is K231493.

When did NITINEX Memory Compression Staple receive FDA 510(k) clearance?

NITINEX Memory Compression Staple received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231493.

Who is the listed applicant for NITINEX Memory Compression Staple?

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

What is the FDA product code for NITINEX Memory Compression Staple?

The FDA product code for NITINEX Memory Compression Staple is JDR.

其他以 Vilex, LLC 為申請人之記錄

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相關器械（代碼：JDR）

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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