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FDA 510(k)

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

K-Number: K253895 · 2025-12-30

ApplicantArthrex, Inc.
Decision Date2025-12-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Arthrex, Inc.. The 510(k) number is K253895.

When was Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm approved by the FDA?

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

What company makes Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm?

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm is manufactured by Arthrex, Inc..

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.

Related Clinical Trials

NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED NCT05753891 Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective) TERMINATED

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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