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FDA 510(k)

Stativ® Knotted UHMWPE Suture Anchor

K-Number: K223889 · 2023-03-22

ApplicantHealthium Medtech Limited
Decision Date2023-03-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stativ® Knotted UHMWPE Suture Anchor is a medical device manufactured by Healthium Medtech Limited. It received FDA 510(k) clearance on 2023-03-22 under approval number K223889. 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 Stativ® Knotted UHMWPE Suture Anchor?

Stativ® Knotted UHMWPE Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Healthium Medtech Limited. The 510(k) number is K223889.

When was Stativ® Knotted UHMWPE Suture Anchor approved by the FDA?

Stativ® Knotted UHMWPE Suture Anchor received FDA 510(k) clearance on 2023-03-22, under approval number K223889.

What company makes Stativ® Knotted UHMWPE Suture Anchor?

Stativ® Knotted UHMWPE Suture Anchor is manufactured by Healthium Medtech Limited.

What is the FDA product code for Stativ® Knotted UHMWPE Suture Anchor?

The FDA product code for Stativ® Knotted UHMWPE 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 Healthium Medtech Limited

K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium Button K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button K231033CEPTRE® Knotted UHMWPE Suture PEEK Anchor

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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