FDA 510(k)

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

Numéro K : K230471 · 2023-03-21

Date de décision2023-03-21

Code produitJWH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K230471. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K230471.

When did LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface receive FDA 510(k) clearance?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface received FDA 510(k) clearance on 2023-03-21, under 510(k) number K230471.

Who is the listed applicant for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is JWH.

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Source officielle

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