FDA 510(k)

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

N.º K: K170942 · 2017-04-26

Fecha de decisión2017-04-26

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170942. 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 The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Choicespine, LP. The 510(k) number is K170942.

When did The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems receive FDA 510(k) clearance?

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170942.

Who is the listed applicant for The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

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

What is the FDA product code for The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems?

The FDA product code for The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems is NKB.

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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

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