FDA 510(k)

IMSE Cervical Cage

Número K: K162003 · 2016-12-21

RequerenteThe Institute of Musculoskeletal Science & Education

Data da decisão2016-12-21

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IMSE Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is The Institute of Musculoskeletal Science & Education. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162003. 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 IMSE Cervical Cage?

IMSE Cervical Cage is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is The Institute of Musculoskeletal Science & Education. The 510(k) number is K162003.

When did IMSE Cervical Cage receive FDA 510(k) clearance?

IMSE Cervical Cage received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162003.

Who is the listed applicant for IMSE Cervical Cage?

The FDA 510(k) record lists The Institute of Musculoskeletal Science & Education as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMSE Cervical Cage?

The FDA product code for IMSE Cervical Cage is ODP.

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