FDA 510(k)

CoCr Head

Número K: K211047 · 2023-01-10

Data da decisão2023-01-10

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoCr Head is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K211047. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoCr Head?

CoCr Head is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Zimmer GmbH. The 510(k) number is K211047.

When did CoCr Head receive FDA 510(k) clearance?

CoCr Head received FDA 510(k) clearance on 2023-01-10, under 510(k) number K211047.

Who is the listed applicant for CoCr Head?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoCr Head?

The FDA product code for CoCr Head is LPH.

Outros registros que listam Zimmer GmbH como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K200814Sistema de Unha Natural Affixus(R) Unha Humeral K200112Zimmer Hip Joint Replacement K193099Sistema de Ombro Anatômico K193050Fêmur Alloclassic Zweymuller SL, Fêmur Alloclassic Zweymuller SL com Desvio, Alloclassic Zweymuller SL K193030Avenir Muller Stem, Avenir Cemented Hip Stem K192236Fitmore Hip Stem

Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: 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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.