FDA 510(k)

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Numéro K : K200328 · 2020-03-11

DemandeurKyocera Medical Technologies, Inc.

Date de décision2020-03-11

Code produitOQG

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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 2020-03-11 under 510(k) number K200328. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2020-03-11. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K200328.

When did Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System receive FDA 510(k) clearance?

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System received FDA 510(k) clearance on 2020-03-11, under 510(k) number K200328.

Who is the listed applicant for Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup 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 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System?

The FDA product code for Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System is OQG.

Essais cliniques associés

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Source officielle

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