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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 the device name listed in this FDA 510(k) record. The listed applicant is Healthium Medtech Limited. It received FDA 510(k) clearance on 2023-11-08 under 510(k) 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. The listed applicant is Healthium Medtech Limited. The 510(k) number is K232886.

When did INFILOOP® Fixed Loop UHMWPE Suture Titanium Button receive FDA 510(k) clearance?

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

Who is the listed applicant for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

The FDA 510(k) record lists Healthium Medtech Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Healthium Medtech Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorK230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantK231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open ButtonK223889Stativ® Knotted UHMWPE Suture Anchor

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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