FDA 510(k)

Anthology Pâtes de Hanche; Pâtes de Hanche CPCS; Têtes Fémorales; Liners Acétabulaires R3; Pâtes de Hanche Spectron; Pâtes de Hanche Synergy

Numéro K : K240783 · 2024-10-21

Date de décision2024-10-21

Code produitJDI

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems 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 2024-10-21 under 510(k) number K240783. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems is a medical device that received FDA 510(k) clearance on 2024-10-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240783.

When did Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems receive FDA 510(k) clearance?

Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems received FDA 510(k) clearance on 2024-10-21, under 510(k) number K240783.

Who is the listed applicant for Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

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 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems?

The FDA product code for Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems is JDI.

Essais cliniques associés

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

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Source officielle

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