FDA 510(k)

Ti-Diagon Oblique TLIF

Número K: K172064 · 2017-09-15

Data da decisão2017-09-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ti-Diagon Oblique TLIF 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 2017-09-15 under 510(k) number K172064. 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 Ti-Diagon Oblique TLIF?

Ti-Diagon Oblique TLIF is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Camber Spine Technologies. The 510(k) number is K172064.

When did Ti-Diagon Oblique TLIF receive FDA 510(k) clearance?

Ti-Diagon Oblique TLIF received FDA 510(k) clearance on 2017-09-15, under 510(k) number K172064.

Who is the listed applicant for Ti-Diagon Oblique TLIF?

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 Ti-Diagon Oblique TLIF?

The FDA product code for Ti-Diagon Oblique TLIF is MAX.

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Fonte oficial

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