FDA 510(k)

EDEN Peek Cage

Número K: K201793 · 2021-09-13

Data da decisão2021-09-13

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EDEN Peek Cage is the device name listed in this FDA 510(k) record. The listed applicant is Jmt Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K201793. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EDEN Peek Cage?

EDEN Peek Cage is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Jmt Co., Ltd.. The 510(k) number is K201793.

When did EDEN Peek Cage receive FDA 510(k) clearance?

EDEN Peek Cage received FDA 510(k) clearance on 2021-09-13, under 510(k) number K201793.

Who is the listed applicant for EDEN Peek Cage?

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

What is the FDA product code for EDEN Peek Cage?

The FDA product code for EDEN Peek Cage is ODP.

Outros registros que listam Jmt Co., Ltd. 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.

K241410EDEN ControlCath K230762EDEN Spinal Fixation MIS System K201788EDEN Spinal Fixation System

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Fonte oficial

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