FDA 510(k)

Catalyst CSR Shoulder System

Номер K: K152825 · 2016-05-11

Дата решения2016-05-11

Код продуктаKWT

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: KWT)

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.