FDA 510(k)

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System

N.º K: K240872 · 2024-04-26

Fecha de decisión2024-04-26

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K240872. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System?

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is Clariance. The 510(k) number is K240872.

When did Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System receive FDA 510(k) clearance?

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System received FDA 510(k) clearance on 2024-04-26, under 510(k) number K240872.

Who is the listed applicant for Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System?

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

What is the FDA product code for Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System?

The FDA product code for Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is NKB.

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Otros registros que enlistan a Clariance como solicitante

K243904Elegance® Anterior Cervical plate K243670Idys® LIF K241863Erisma® Lp Spinal Fixation System; Erisma® LP MIS K240715Idys® C ZP 3DTi K220182Aggeris™-C K200919Idys ALIF 3DTi

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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