FDA 510(k)

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

Numéro K : K231404 · 2023-08-04

Date de décision2023-08-04

Code produitMBI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open 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 2023-08-04 under 510(k) number K231404. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Healthium Medtech Limited. The 510(k) number is K231404.

When did T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button receive FDA 510(k) clearance?

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231404.

Who is the listed applicant for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open 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 T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

The FDA product code for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is MBI.

Essais cliniques associés

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Autres dossiers indiquant Healthium Medtech Limited en tant que demandeur

K231033CEPTRE® Knotted UHMWPE Suture PEEK Anchor K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium Button K223889Stativ® Knotted UHMWPE Suture Anchor

Dispositifs connexes (Code : MBI)

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Source officielle

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