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FDA 510(k)

Aevumed FENIX Suture Anchor

K-Number: K254306 · 2026-03-04

ApplicantAevumed, Inc.
Decision Date2026-03-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aevumed FENIX Suture Anchor is a medical device manufactured by Aevumed, Inc.. It received FDA 510(k) clearance on 2026-03-04 under approval number K254306. 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 Aevumed FENIX Suture Anchor?

Aevumed FENIX Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-03-04. It is manufactured by Aevumed, Inc.. The 510(k) number is K254306.

When was Aevumed FENIX Suture Anchor approved by the FDA?

Aevumed FENIX Suture Anchor received FDA 510(k) clearance on 2026-03-04, under approval number K254306.

What company makes Aevumed FENIX Suture Anchor?

Aevumed FENIX Suture Anchor is manufactured by Aevumed, Inc..

What is the FDA product code for Aevumed FENIX Suture Anchor?

The FDA product code for Aevumed FENIX Suture Anchor is MBI.

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)

Other Devices by Aevumed, Inc.

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View all 7 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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