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FDA 510(k)

Arthrex PushLock Suture Anchors

K-Number: K251145 · 2025-07-10

ApplicantArthrex, Inc.
Decision Date2025-07-10
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex PushLock Suture Anchors is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K251145. 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 Arthrex PushLock Suture Anchors?

Arthrex PushLock Suture Anchors is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Arthrex, Inc.. The 510(k) number is K251145.

When was Arthrex PushLock Suture Anchors approved by the FDA?

Arthrex PushLock Suture Anchors received FDA 510(k) clearance on 2025-07-10, under approval number K251145.

What company makes Arthrex PushLock Suture Anchors?

Arthrex PushLock Suture Anchors is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex PushLock Suture Anchors?

The FDA product code for Arthrex PushLock Suture Anchors is MBI.

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 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)

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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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