FDA 510(k)

Restrata 软组织加固（STR）

K号: K251224 · 2025-06-20

决定日期2025-06-20

产品代码OXF

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决定实质等同

器械摘要

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.

常见问题

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.

列明Acera Surgical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。