FDA 510(k)

TriMed Humeral Supracondylar Fixation System

N.º K: K151735 · 2016-01-29

Fecha de decisión2016-01-29

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

TriMed Humeral Supracondylar Fixation 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 2016-01-29 under 510(k) number K151735. 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 TriMed Humeral Supracondylar Fixation System?

TriMed Humeral Supracondylar Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is TriMed, Inc.. The 510(k) number is K151735.

When did TriMed Humeral Supracondylar Fixation System receive FDA 510(k) clearance?

TriMed Humeral Supracondylar Fixation System received FDA 510(k) clearance on 2016-01-29, under 510(k) number K151735.

Who is the listed applicant for TriMed Humeral Supracondylar Fixation 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 TriMed Humeral Supracondylar Fixation System?

The FDA product code for TriMed Humeral Supracondylar Fixation 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)K252061Distal Xtremities System K251134RipCord

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Fuente oficial

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