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FDA 510(k)

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

K-Number: K232886 · 2023-11-08

ApplicantHealthium Medtech Limited
Decision Date2023-11-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a medical device manufactured by Healthium Medtech Limited. It received FDA 510(k) clearance on 2023-11-08 under approval number K232886. 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 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a medical device that received FDA 510(k) clearance on 2023-11-08. It is manufactured by Healthium Medtech Limited. The 510(k) number is K232886.

When was INFILOOP® Fixed Loop UHMWPE Suture Titanium Button approved by the FDA?

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button received FDA 510(k) clearance on 2023-11-08, under approval number K232886.

What company makes INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is manufactured by Healthium Medtech Limited.

What is the FDA product code for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

The FDA product code for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is MBI.

Related Clinical Trials

NCT07538869 Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer COMPLETED

Other Devices by Healthium Medtech Limited

K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button K223889Stativ® Knotted UHMWPE Suture Anchor K231033CEPTRE® Knotted UHMWPE Suture PEEK Anchor

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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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