FDA 510(k)

NITRO Interbody Fusion Cage System Family

N.º K: K220513 · 2023-04-25

Fecha de decisión2023-04-25

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NITRO Interbody Fusion Cage System Family 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 2023-04-25 under 510(k) number K220513. 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 NITRO Interbody Fusion Cage System Family?

NITRO Interbody Fusion Cage System Family is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Ctl Medical Corporation. The 510(k) number is K220513.

When did NITRO Interbody Fusion Cage System Family receive FDA 510(k) clearance?

NITRO Interbody Fusion Cage System Family received FDA 510(k) clearance on 2023-04-25, under 510(k) number K220513.

Who is the listed applicant for NITRO Interbody Fusion Cage System Family?

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 NITRO Interbody Fusion Cage System Family?

The FDA product code for NITRO Interbody Fusion Cage System Family 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 K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System K213641MONDRIAN ALIF Cage with Supplementary Fixation Plate

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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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