FDA 510(k)

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

Numéro K : K242711 · 2024-10-30

Date de décision2024-10-30

Code produitHSX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) 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 2024-10-30 under 510(k) number K242711. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K242711.

When did JOURNEY II Unicompartmental Knee System (JOURNEY II UK) receive FDA 510(k) clearance?

JOURNEY II Unicompartmental Knee System (JOURNEY II UK) received FDA 510(k) clearance on 2024-10-30, under 510(k) number K242711.

Who is the listed applicant for JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

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 JOURNEY II Unicompartmental Knee System (JOURNEY II UK)?

The FDA product code for JOURNEY II Unicompartmental Knee System (JOURNEY II UK) is HSX.

Essais cliniques associés

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Autres dossiers indiquant Smith & Nephew, Inc. en tant que demandeur

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)K254084Système d'épaule AETOS - CONCELOC Glenoids K252416Prothèse humérale métatrophe AETOS Taille 0 K252129Prothèse humérale AETOS sans tige 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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Dispositifs connexes (Code : HSX)

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Source officielle

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