FDA 510(k)

Restrata軟組織加固（STR）

K 號：K251224 · 2025-06-20

決定日期2025-06-20

產品代碼OXF

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

Restrata Soft Tissue Reinforcement (STR) is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K251224. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Restrata Soft Tissue Reinforcement (STR)?

Restrata Soft Tissue Reinforcement (STR) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K251224.

When did Restrata Soft Tissue Reinforcement (STR) receive FDA 510(k) clearance?

Restrata Soft Tissue Reinforcement (STR) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K251224.

Who is the listed applicant for Restrata Soft Tissue Reinforcement (STR)?

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

What is the FDA product code for Restrata Soft Tissue Reinforcement (STR)?

The FDA product code for Restrata Soft Tissue Reinforcement (STR) is OXF.

其他以 Acera Surgical, Inc. 為申請人之記錄

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相關器械（代碼：OXF）

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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