FDA 510(k)

CarboClear Cervical Cage System, CarboClear Cervical VBR System

N.º K: K222874 · 2023-07-26

Fecha de decisión2023-07-26

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CarboClear Cervical Cage System, CarboClear Cervical VBR 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 2023-07-26 under 510(k) number K222874. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CarboClear Cervical Cage System, CarboClear Cervical VBR System?

CarboClear Cervical Cage System, CarboClear Cervical VBR System is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Carbofix Orthpedics , Ltd.. The 510(k) number is K222874.

When did CarboClear Cervical Cage System, CarboClear Cervical VBR System receive FDA 510(k) clearance?

CarboClear Cervical Cage System, CarboClear Cervical VBR System received FDA 510(k) clearance on 2023-07-26, under 510(k) number K222874.

Who is the listed applicant for CarboClear Cervical Cage System, CarboClear Cervical VBR 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 Cervical Cage System, CarboClear Cervical VBR System?

The FDA product code for CarboClear Cervical Cage System, CarboClear Cervical VBR System is ODP.

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Otros registros que enlistan a Carbofix Orthpedics , Ltd. como solicitante

K203683CarboClear Lumbar Cage System

Dispositivos relacionados (Código: ODP)

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Fuente oficial

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