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FDA 510(k)

Arthrex Nano SwiveLock Suture Anchor

K-Number: K191651 · 2019-11-06

ApplicantArthrex, Inc.
Decision Date2019-11-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Nano SwiveLock Suture Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-11-06 under approval number K191651. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Nano SwiveLock Suture Anchor?

Arthrex Nano SwiveLock Suture Anchor is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Arthrex, Inc.. The 510(k) number is K191651.

When was Arthrex Nano SwiveLock Suture Anchor approved by the FDA?

Arthrex Nano SwiveLock Suture Anchor received FDA 510(k) clearance on 2019-11-06, under approval number K191651.

What company makes Arthrex Nano SwiveLock Suture Anchor?

Arthrex Nano SwiveLock Suture Anchor is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Nano SwiveLock Suture Anchor?

The FDA product code for Arthrex Nano SwiveLock Suture Anchor is HWC. This falls under the Cardiovascular category.

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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