FDA 510(k)

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

Número K: K182151 · 2018-10-11

Data da decisão2018-10-11

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate 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 2018-10-11 under 510(k) number K182151. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Ctl Medical Corporation. The 510(k) number is K182151.

When did MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate receive FDA 510(k) clearance?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182151.

Who is the listed applicant for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

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 MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

The FDA product code for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is OVE.

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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 K231359RODIN™ Expandable Lumbar Cage System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System

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Dispositivos Relacionados (Código: OVE)

K263049SABER-C SystemElevation Spine K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.

Fonte oficial

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