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FDA 510(k)

Aevumed PROTEKT Suture Anchor

K-Number: K260004 · 2026-01-28

ApplicantAevumed, Inc.
Decision Date2026-01-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aevumed PROTEKT Suture Anchor is a medical device manufactured by Aevumed, Inc.. It received FDA 510(k) clearance on 2026-01-28 under approval number K260004. 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 PROTEKT Suture Anchor?

Aevumed PROTEKT Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Aevumed, Inc.. The 510(k) number is K260004.

When was Aevumed PROTEKT Suture Anchor approved by the FDA?

Aevumed PROTEKT Suture Anchor received FDA 510(k) clearance on 2026-01-28, under approval number K260004.

What company makes Aevumed PROTEKT Suture Anchor?

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

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

The FDA product code for Aevumed PROTEKT 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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