FDA 510(k)

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™

N.º K: K172212 · 2018-01-09

Fecha de decisión2018-01-09

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ 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 2018-01-09 under 510(k) number K172212. 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 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™?

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Ctl Medical Corporation. The 510(k) number is K172212.

When did MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ receive FDA 510(k) clearance?

MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ received FDA 510(k) clearance on 2018-01-09, under 510(k) number K172212.

Who is the listed applicant for MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™?

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 MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™?

The FDA product code for MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ is ODP.

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Otros registros que enlistan a Ctl Medical Corporation como solicitante

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: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fuente oficial

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