FDA 510(k)

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE

Numéro K : K211768 · 2021-06-30

Date de décision2021-06-30

Code produitKRO

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE 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 2021-06-30 under 510(k) number K211768. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE?

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K211768.

When did LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE receive FDA 510(k) clearance?

LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE received FDA 510(k) clearance on 2021-06-30, under 510(k) number K211768.

Who is the listed applicant for LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE?

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 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE?

The FDA product code for LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE is KRO.

Essais cliniques associés

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Autres dossiers indiquant Waldemar Link GmbH & Co. KG en tant que demandeur

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Dispositifs connexes (Code : KRO)

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Source officielle

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