FDA 510(k)

Latitud Hip Replacement System

Número K: K183532 · 2019-07-18

Data da decisão2019-07-18

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Latitud Hip Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K183532. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Latitud Hip Replacement System?

Latitud Hip Replacement System is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Meril Healthcare Pvt. , Ltd.. The 510(k) number is K183532.

When did Latitud Hip Replacement System receive FDA 510(k) clearance?

Latitud Hip Replacement System received FDA 510(k) clearance on 2019-07-18, under 510(k) number K183532.

Who is the listed applicant for Latitud Hip Replacement System?

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

What is the FDA product code for Latitud Hip Replacement System?

The FDA product code for Latitud Hip Replacement System is LZO.

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Outros registros que listam Meril Healthcare Pvt. , Ltd. como candidato(a)

K222436Latitud™ Hip Replacement System K222816Opulent TiNbN Coated Knee K212839Opulent TiNbN Coated Knee K172857Latitud Hip Replacement System K171320Pranchas e Parafusos MBOSS / FIXION Pequenos Fragmentos e Tálus ARMAR / ARTIS, Pranchas e Parafusos do Humero e Olecrano ARMAR / ARTIS, Pranchas e Parafusos Tibiais e de Suporte ARMAR / ARTIS, Pranchas ARMAR / ARTIS 2.4mm e Parafusos MBOSS / FIXION, Prancha de Gancho Clavicular ARMAR / ARTIS e Parafusos MBOSS / FIXION, Prancha Metáfise ARMAR / ARTIS e Parafusos MBOSS / FIXION, Prancha de Tálus ARMAR / ARTIS e Parafusos MBOSS / FIXION K172936Destiknee™ Total Knee System

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Fonte oficial

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