FDA 510(k)

CORIOGRAPH Knee Pre-Op Plan

Número K: K240113 · 2024-03-18

Data da decisão2024-03-18

Código do produtoPBF

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CORIOGRAPH Knee Pre-Op Plan 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 2024-03-18 under 510(k) number K240113. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CORIOGRAPH Knee Pre-Op Plan?

CORIOGRAPH Knee Pre-Op Plan is a medical device that received FDA 510(k) clearance on 2024-03-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240113.

When did CORIOGRAPH Knee Pre-Op Plan receive FDA 510(k) clearance?

CORIOGRAPH Knee Pre-Op Plan received FDA 510(k) clearance on 2024-03-18, under 510(k) number K240113.

Who is the listed applicant for CORIOGRAPH Knee Pre-Op Plan?

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 CORIOGRAPH Knee Pre-Op Plan?

The FDA product code for CORIOGRAPH Knee Pre-Op Plan is PBF.

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Outros registros que listam Smith & Nephew, Inc. como candidato(a)

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 Ombro AETOS - CONCELOC Glenoids K252416Prótese Metacôndila AETOS Shoulder System Size 0 K252129Prótese de Humeral AETOS Shoulder System Sem Cabeça 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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Fonte oficial

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