FDA 510(k)

SPIRA Open Matrix ALIF

Número K: K162986 · 2017-06-12

Data da decisão2017-06-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPIRA Open Matrix ALIF is the device name listed in this FDA 510(k) record. The listed applicant is Camber Spine Technologies. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162986. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SPIRA Open Matrix ALIF?

SPIRA Open Matrix ALIF is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is Camber Spine Technologies. The 510(k) number is K162986.

When did SPIRA Open Matrix ALIF receive FDA 510(k) clearance?

SPIRA Open Matrix ALIF received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162986.

Who is the listed applicant for SPIRA Open Matrix ALIF?

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

What is the FDA product code for SPIRA Open Matrix ALIF?

The FDA product code for SPIRA Open Matrix ALIF is MAX.

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Fonte oficial

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