FDA 510(k)

Prótesis Humeral Sin Cuello AETOS Shoulder System

N.º K: K252129 · 2025-10-03

Fecha de decisión2025-10-03

Código de productoPKC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AETOS Shoulder System Stemless Humeral Prosthesis 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 2025-10-03 under 510(k) number K252129. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AETOS Shoulder System Stemless Humeral Prosthesis?

AETOS Shoulder System Stemless Humeral Prosthesis is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K252129.

When did AETOS Shoulder System Stemless Humeral Prosthesis receive FDA 510(k) clearance?

AETOS Shoulder System Stemless Humeral Prosthesis received FDA 510(k) clearance on 2025-10-03, under 510(k) number K252129.

Who is the listed applicant for AETOS Shoulder System Stemless Humeral Prosthesis?

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 AETOS Shoulder System Stemless Humeral Prosthesis?

The FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis is PKC.

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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 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)K243608TRIGEN Stable Lock Nut & Washer

Ver todos los 112 dispositivos →

Dispositivos relacionados (Código: PKC)

K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716Prótesis Humeral Sin Cuello AETOS Shoulder SystemSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

Fuente oficial

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