FDA 510(k)

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

K-Nummer: K242711 · 2024-10-30

Entscheidungsdatum2024-10-30

ProduktcodeHSX

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Smith & Nephew, Inc. als Antragsteller

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)K254084AETOS Shoulder System - CONCELOC Glenoids K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis 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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Offizielle Quelle

In der FDA-Datenbank anzeigen →

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