FDA 510(k)

Initia T3 Acetabular Hemispherical Shell System

Numéro K : K242045 · 2025-04-10

DemandeurKyocera Medical Technologies, Inc.

Date de décision2025-04-10

Code produitLPH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Initia T3 Acetabular Hemispherical Shell System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K242045. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Initia T3 Acetabular Hemispherical Shell System?

Initia T3 Acetabular Hemispherical Shell System is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K242045.

When did Initia T3 Acetabular Hemispherical Shell System receive FDA 510(k) clearance?

Initia T3 Acetabular Hemispherical Shell System received FDA 510(k) clearance on 2025-04-10, under 510(k) number K242045.

Who is the listed applicant for Initia T3 Acetabular Hemispherical Shell System?

The FDA 510(k) record lists Kyocera Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Initia T3 Acetabular Hemispherical Shell System?

The FDA product code for Initia T3 Acetabular Hemispherical Shell System is LPH.

Essais cliniques associés

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Source officielle

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