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FDA 510(k)

Aevumed PHANTOM Suture Anchors

K-Number: K242895 · 2025-08-06

ApplicantAevumed, Inc.
Decision Date2025-08-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aevumed PHANTOM Suture Anchors is a medical device manufactured by Aevumed, Inc.. It received FDA 510(k) clearance on 2025-08-06 under approval number K242895. 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 PHANTOM Suture Anchors?

Aevumed PHANTOM Suture Anchors is a medical device that received FDA 510(k) clearance on 2025-08-06. It is manufactured by Aevumed, Inc.. The 510(k) number is K242895.

When was Aevumed PHANTOM Suture Anchors approved by the FDA?

Aevumed PHANTOM Suture Anchors received FDA 510(k) clearance on 2025-08-06, under approval number K242895.

What company makes Aevumed PHANTOM Suture Anchors?

Aevumed PHANTOM Suture Anchors is manufactured by Aevumed, Inc..

What is the FDA product code for Aevumed PHANTOM Suture Anchors?

The FDA product code for Aevumed PHANTOM Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

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.

K180464AEVUMED PHANTOM Suture Anchors K222363Aevumed PHANTOM™-LP Suture Anchors K223878Aevumed RAPID Suture Anchors K253040Aevumed FASE Suture Anchor K254306Aevumed FENIX Suture Anchor K260004Aevumed PROTEKT Suture Anchor

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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