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FDA 510(k)

預縫合腱（4561SC / 单股）；預縫合腱（4564SC / 四股）

K 號：K230036 · 2023-06-23

申請人Rti Surgical, Inc.
決定日期2023-06-23
產品代碼GAT
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K230036. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K230036.

When did Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) receive FDA 510(k) clearance?

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) received FDA 510(k) clearance on 2023-06-23, under 510(k) number K230036.

Who is the listed applicant for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

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

What is the FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )?

The FDA product code for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) is GAT.

相關臨床試驗

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其他以 Rti Surgical, Inc. 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：GAT）

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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