FDA 510(k)

Aevumed FENIX Suture Anchor

K-Number: K254306 · 2026-03-04

Decision Date2026-03-04

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Aevumed FENIX Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Aevumed, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) 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. The listed applicant is Aevumed, Inc.. The 510(k) number is K254306.

When did Aevumed FENIX Suture Anchor receive FDA 510(k) clearance?

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

Who is the listed applicant for Aevumed FENIX Suture Anchor?

The FDA 510(k) record lists Aevumed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Aevumed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260004Aevumed PROTEKT Suture Anchor K253040Aevumed FASE Suture Anchor K242895Aevumed PHANTOM Suture Anchors K223878Aevumed RAPID Suture Anchors K222363Aevumed PHANTOM™-LP Suture Anchors K180464AEVUMED PHANTOM Suture Anchors

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Related Devices (Code: MBI)

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy K261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

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