FDA 510(k)

Episealer Patellofemoral System

Номер K: K221048 · 2022-12-23

Дата решения2022-12-23

Код продуктаKRR

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Episealer Patellofemoral System is the device name listed in this FDA 510(k) record. The listed applicant is Episurf Medical, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K221048. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Episealer Patellofemoral System?

Episealer Patellofemoral System is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Episurf Medical, Inc.. The 510(k) number is K221048.

When did Episealer Patellofemoral System receive FDA 510(k) clearance?

Episealer Patellofemoral System received FDA 510(k) clearance on 2022-12-23, under 510(k) number K221048.

Who is the listed applicant for Episealer Patellofemoral System?

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

What is the FDA product code for Episealer Patellofemoral System?

The FDA product code for Episealer Patellofemoral System is KRR.

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.

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Связанные устройства (Код: KRR)

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics K200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Система артропластики Arthrex iBalance BiCompartmentalArthrex, Inc.

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