FDA 510(k)

カタリスト CSR 肩関節システム

K番号: K152825 · 2016-05-11

決定日2016-05-11

製品コードKWT

諮問委員会OR

決定Substantially Equivalent

医療機器の概要

Catalyst CSR Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, LLC. It received FDA 510(k) clearance on 2016-05-11 under 510(k) number K152825. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Catalyst CSR Shoulder System?

Catalyst CSR Shoulder System is a medical device that received FDA 510(k) clearance on 2016-05-11. The listed applicant is Catalyst Orthoscience, LLC. The 510(k) number is K152825.

When did Catalyst CSR Shoulder System receive FDA 510(k) clearance?

Catalyst CSR Shoulder System received FDA 510(k) clearance on 2016-05-11, under 510(k) number K152825.

Who is the listed applicant for Catalyst CSR Shoulder System?

The FDA 510(k) record lists Catalyst Orthoscience, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalyst CSR Shoulder System?

The FDA product code for Catalyst CSR Shoulder System is KWT.

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カタリスト CSR 肩関節システム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KWT）

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