FDA 510(k)

CarboClear Lumbar Cage System

Número K: K203683 · 2021-01-15

Data da decisão2021-01-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CarboClear Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Carbofix Orthpedics , Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203683. 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 CarboClear Lumbar Cage System?

CarboClear Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Carbofix Orthpedics , Ltd.. The 510(k) number is K203683.

When did CarboClear Lumbar Cage System receive FDA 510(k) clearance?

CarboClear Lumbar Cage System received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203683.

Who is the listed applicant for CarboClear Lumbar Cage System?

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

What is the FDA product code for CarboClear Lumbar Cage System?

The FDA product code for CarboClear Lumbar Cage System is MAX.

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