FDA 510(k)

DePuy 3D Additive TriFlange Acetabular Cup

Номер K: K201348 · 2022-06-16

Дата решения2022-06-16

Код продуктаLPH

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

DePuy 3D Additive TriFlange Acetabular Cup is the device name listed in this FDA 510(k) record. The listed applicant is Depuy International, Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K201348. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DePuy 3D Additive TriFlange Acetabular Cup?

DePuy 3D Additive TriFlange Acetabular Cup is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Depuy International, Ltd.. The 510(k) number is K201348.

When did DePuy 3D Additive TriFlange Acetabular Cup receive FDA 510(k) clearance?

DePuy 3D Additive TriFlange Acetabular Cup received FDA 510(k) clearance on 2022-06-16, under 510(k) number K201348.

Who is the listed applicant for DePuy 3D Additive TriFlange Acetabular Cup?

The FDA 510(k) record lists Depuy International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy 3D Additive TriFlange Acetabular Cup?

The FDA product code for DePuy 3D Additive TriFlange Acetabular Cup is LPH.

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: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Официальный источник

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