FDA 510(k)

RODIN™ Expandable Lumbar Cage System

Número K: K231359 · 2023-06-09

Data da decisão2023-06-09

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RODIN™ Expandable Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K231359. 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 RODIN™ Expandable Lumbar Cage System?

RODIN™ Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Ctl Medical Corporation. The 510(k) number is K231359.

When did RODIN™ Expandable Lumbar Cage System receive FDA 510(k) clearance?

RODIN™ Expandable Lumbar Cage System received FDA 510(k) clearance on 2023-06-09, under 510(k) number K231359.

Who is the listed applicant for RODIN™ Expandable Lumbar Cage System?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RODIN™ Expandable Lumbar Cage System?

The FDA product code for RODIN™ Expandable Lumbar Cage System is MAX.

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Outros registros que listam Ctl Medical Corporation como candidato(a)

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System K231715MONDRIAN™ Anterior Lumbar Plate System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System K213641MONDRIAN ALIF Cage with Supplementary Fixation Plate

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Fonte oficial

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