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FDA 510(k)

Arthrex FiberTak Suture Anchor

K-Number: K231113 · 2023-05-18

ApplicantArthrex, Inc.
Decision Date2023-05-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FiberTak Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-05-18 under approval number K231113. 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 FiberTak Suture Anchor?

Arthrex FiberTak Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-05-18. It is manufactured by Arthrex, Inc.. The 510(k) number is K231113.

When was Arthrex FiberTak Suture Anchor approved by the FDA?

Arthrex FiberTak Suture Anchor received FDA 510(k) clearance on 2023-05-18, under approval number K231113.

What company makes Arthrex FiberTak Suture Anchor?

Arthrex FiberTak Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex FiberTak Suture Anchor?

The FDA product code for Arthrex FiberTak Suture Anchor 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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Related Devices (Code: MBI)

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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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