FDA 510(k)

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System

N.º K: K240061 · 2024-09-20

Fecha de decisión2024-09-20

Código de productoJDS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture 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 2024-09-20 under 510(k) number K240061. 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 MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240061.

When did TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System receive FDA 510(k) clearance?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240061.

Who is the listed applicant for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture 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 MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

The FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture 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)

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Dispositivos relacionados (Código: JDS)

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K241804Sistema de Uñas INTERTAN 10S TRIGENSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC K192003Auxein Nailing SystemAuxein Medical Private Limited

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.