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FDA 510(k)

Arthrex 3.9mm Corkscrew Suture Anchor

K-Number: K193157 · 2019-12-12

ApplicantArthrex, Inc.
Decision Date2019-12-12
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 3.9mm Corkscrew Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-12-12 under approval number K193157. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex 3.9mm Corkscrew Suture Anchor?

Arthrex 3.9mm Corkscrew Suture Anchor is a medical device that received FDA 510(k) clearance on 2019-12-12. It is manufactured by Arthrex, Inc.. The 510(k) number is K193157.

When was Arthrex 3.9mm Corkscrew Suture Anchor approved by the FDA?

Arthrex 3.9mm Corkscrew Suture Anchor received FDA 510(k) clearance on 2019-12-12, under approval number K193157.

What company makes Arthrex 3.9mm Corkscrew Suture Anchor?

Arthrex 3.9mm Corkscrew Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex 3.9mm Corkscrew Suture Anchor?

The FDA product code for Arthrex 3.9mm Corkscrew Suture Anchor is MAI.

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: MAI)

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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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