FDA 510(k)

TRIGEN META-NAIL Nail System

N.º K: K230761 · 2023-06-14

Fecha de decisión2023-06-14

Código de productoJDS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRIGEN META-NAIL Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2023-06-14 under 510(k) number K230761. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the TRIGEN META-NAIL Nail System?

TRIGEN META-NAIL Nail System is a medical device that received FDA 510(k) clearance on 2023-06-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K230761.

When did TRIGEN META-NAIL Nail System receive FDA 510(k) clearance?

TRIGEN META-NAIL Nail System received FDA 510(k) clearance on 2023-06-14, under 510(k) number K230761.

Who is the listed applicant for TRIGEN META-NAIL Nail System?

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

What is the FDA product code for TRIGEN META-NAIL Nail System?

The FDA product code for TRIGEN META-NAIL Nail System is JDS.

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Otros registros que enlistan a Smith & Nephew, Inc. como solicitante

K261462LANDMARK Total Knee System 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)K254084Sistema de Hombro AETOS - CONCELOC Glenoids K252416Prótesis Humeral Meta AETOS Shoulder System Size 0 K252129Prótesis Humeral Sin Cuello AETOS Shoulder System K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

Ver todos los 112 dispositivos →

Dispositivos relacionados (Código: JDS)

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Fuente oficial

Ver en la base de datos de la FDA →

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