FDA 510(k)

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

K号: K253895 · 2025-12-30

决定日期2025-12-30

产品代码MBI

咨询委员会OR

决定Substantially Equivalent

器械摘要

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K253895. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm?

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Arthrex, Inc.. The 510(k) number is K253895.

When did Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm receive FDA 510(k) clearance?

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm received FDA 510(k) clearance on 2025-12-30, under 510(k) number K253895.

Who is the listed applicant for Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm?

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

What is the FDA product code for Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm?

The FDA product code for Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is MBI.

列明Arthrex, 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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