FDA 510(k)

Distal Xtremities System

N.º K: K252061 · 2025-08-20

Fecha de decisión2025-08-20

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Distal Xtremities System is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K252061. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Distal Xtremities System?

Distal Xtremities System is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is TriMed, Inc.. The 510(k) number is K252061.

When did Distal Xtremities System receive FDA 510(k) clearance?

Distal Xtremities System received FDA 510(k) clearance on 2025-08-20, under 510(k) number K252061.

Who is the listed applicant for Distal Xtremities System?

The FDA 510(k) record lists TriMed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Distal Xtremities System?

The FDA product code for Distal Xtremities System is HRS.

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Otros registros que enlistan a TriMed, Inc. como solicitante

K262344Large Compression Screws K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )K261241TriMed Compression Screws K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)K251134RipCord K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

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Fuente oficial

Ver en la base de datos de la FDA →

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